FDA > CDRH > MedSun > Newsletter #25, June 2008

Newsletter #25, June 2008

Articles

Concerns with Heparin

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The recent serious injuries and deaths associated with the use of potentially contaminated heparin are of great interest at this time. The following links contain information about the ongoing heparin issue.

Additional Information:

Heparin Sodium Injection. FDA Website. May 15, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2

Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated. FDA Website. April 8, 2008.
http://www.fda.gov/cdrh/safety/heparin-notice.html

LabNet

Focuses on promoting awareness of medical devices in hospital laboratories and reporting identified problems to FDA’s Office of In Vitro Diagnostics. To see recently submitted MedSun Laboratory Device Reports, see Laboratory/In Vitro Diagnostic Devices.

Gaines, Ann Reed; Pierce, L. Ross; Bernhardt, Patricia A.
FDA Center for Biologics Evaluation and Research Website

The FDA received a case report of an elderly male diabetic patient that received a 10% maltose-containing intravenous immune globulin product. He later went into a hypoglycemic coma and had irreversible neurological damage secondary to excessive insulin administration. His insulin dosing was guided by falsely elevated blood glucose measurements obtained from a point-of-care glucose meter. Some glucose meter test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) methodology may overestimate measurements when blood maltose levels exceed 0.9mmol/L.

Additional Information:

Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product. Gaines, Ann Reed; Pierce, L. Ross; Bernhardt, Patricia A.
http://www.fda.gov/cber/safety/glucfalse.htm

Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations

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The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 189,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. For more information on Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations please visit the website below:

Additional Information:

Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations. FDA Website.

http://www.cms.hhs.gov/CLIA/downloads/DIrect_Access_Testing_(DAT).pdf

2008 National Patient Safety Goals Laboratory Services Program

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Joint Commission Journal on Quality and Patient Safety

2008 National Patient Safety Goals Manual Chapter
(Includes Rationales and Implementation Expectations)

Note: Gaps in the numbering indicate that the Goal is inapplicable to the program or has been "retired," usually because the requirements were integrated into the standards.

Goal 1 Improve the accuracy of patient identification.
1A. Use at least two patient identifiers when providing care, treatment or services.
1B. Prior to the start of any invasive procedure, conduct a final verification process (such as a "time out") to confirm the correct patient, procedure and site, using active—not passive—communication techniques.

Goal 2 Improve the effectiveness of communication among caregivers.
2A. For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the information record and "read-back" the complete order or test result.
2B. Standardize a list of abbreviations, acronyms, symbols, and dose designations that are not to be used throughout the organization.
2C. Measure and assess, and if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values.
2E. Implement a standardized approach to “hand off” communications, including an opportunity to ask and respond to questions.

Goal 7 Reduce the risk of health care-associated infections.
7A. Comply with current World Health Organization (WHO) Hand Hygiene Guidelines or Centers for Disease Control and Prevention (CDC) hand hygiene guidelines.
7B. Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a health care-associated infection.

Goal 13 Encourage patients’ active involvement in their own care as a patient safety strategy.
13A. Define and communicate the means for patients and their families to report concerns about safety and encourage them to do so.

Additional Information:

2008 National Patient Safety Goals Laboratory Services Program. Joint Commission Journal on Quality and Patient Safety.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/08_lab_npsgs.htm

Recognizing the Sources of Interference with Immunoassays

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Amitava Dasgupta, PhD, DABCC
American Association for Clinical Chemistry - Clinical Laboratory News

Therapeutic drug monitoring (TDM) has improved patient care but studies suggest that improvements can be made. Until superior, less time-consuming methods are available, laboratorians need to be proactive in educating clinicians about the limitations of assays for certain therapeutic drugs. Implementing these programs requires a major commitment and resources from the lab. To be successful, laboratorians need to provide clinicians with ongoing education, such as bulletins and newsletters, to keep them current with information about the assays.

Additional Information:

Recognizing the Sources of Interference with Immunoassays. Amitava Dasgupta, PhD, DABCC. American Association for Clinical Chemistry - Clinical Laboratory News. April 2008.
http://www.aacc.org/publications/cln/2008/april/Pages/series_0408.aspx

HeartNet

Focuses on identifying, understanding, and solving problems with medical devices used in electrophysiology laboratories. To see recently submitted MedSun Cardiovascular and EP Device Reports, see Cardiovascular including EP Devices.

For more details about heart devices visit Heart Health.

Jones, SO; Eckart, RE; Albert CM; Epstein LM
Arrhythmia Service, Department of Cardiovascular Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts

PubMed

BACKGROUND: Lead extraction is increasingly necessary given the exponential growth in cardiac device implantation. Meanwhile, the tools, indications, and outcomes of this procedure continue to change.

OBJECTIVE: The purpose of this study was to examine contemporary indications, outcomes, and complications of transvenous lead extraction in a large series of patients at a high-volume lead extraction center.

METHODS: We performed a retrospective cohort study of consecutive patients undergoing lead extraction at a single, high-volume center. Patient and lead characteristics and the indications, outcomes, and need for laser assistance were analyzed.

RESULTS: From January 2000 to March 2007, a total of 975 chronic endovascular leads were removed from 498 patients. Median implant duration was 5.7 years (range 0.5-32.7 years). Indications were infection (60.3%), mechanical lead failure (29.3%), and upgrade of device system (8.8%). Over the study period, lead malfunction decreased relative to other indications. Laser assistance for extraction was more likely with leads implanted longer than 3.4 years compared to less than 3.4 years (odds ratio 6.15, 95% confidence interval 3.35-11.28) and with implantable cardioverter-defibrillator leads compared to pacemaker leads (odds ratio 3.44, 95% confidence interval 1.84-6.43). Overall, 97.5% of the leads were completely removed. Major complications occurred in 2 (0.4%) patients. Only one patient required cardiac surgery. No deaths occurred. CONCLUSION: In a high-volume center, lead extraction has a high success rate and low complication rate. Infection was the most common indication overall. Lead failure has decreased in relative proportion. Implantable cardioverter-defibrillator leads and longer lead implant time are associated with a requirement for laser lead extraction.

Additional Information:

Large, Single-Center, Single-Operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications. Jones, SO, et al. Arrhythmia Service, Department of Cardiovascular Medicine, Brigham and Women’s Hospital
http://www.ncbi.nlm.nih.gov/pubmed/18325849

Design of the Pacemaker Remote Follow-up Evaluation and Review (PREFER) Trial to Assess the Clinical Value of the Remote Pacemaker Interrogation in the Management of Pacemaker Patients

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Chen, J; Wilkoff, BL; Choucair, W; Cohen, TJ; Crossley, et al
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio

PubMed

ABSTRACT
BACKGROUND: Although pacemakers are primarily used for the treatment of bradycardia, diagnostic data available in current pacemakers allow them to be also used as sophisticated, continuous monitoring devices. Easy access to these stored data may assist clinicians in making diagnostic and therapeutic decisions sooner, thus avoiding potential long-term sequelae due to untreated clinical disorders. Internet-based remote device interrogation systems provide clinicians with frequent and complete access to stored data in pacemakers. In addition to monitoring device function, remote monitors may be a helpful tool in assisting physicians in the management of common arrhythmia disorders.

METHODS: The Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial is a prospective, randomized, parallel, unblinded, multicenter, open label clinical trial to determine the utility of remote pacemaker interrogation in the earlier diagnosis of clinically actionable events compared to the existing practice of transtelephonic monitoring. There have been 980 patients enrolled and randomized to receive pacemaker follow up with either remote interrogation using the Medtronic CareLink(R) Network (CareLink) versus the conventional method of transtelephonic monitoring (TTM) in addition to periodic in-person interrogation and programming evaluations. The purpose of this manuscript is to describe the design of the PREFER trial. The results, to be presented separately, will characterize the number of clinically actionable events as a result of pacemaker follow-up using remote interrogation instead of TTM. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00294645

Additional Information:

Design of the Pacemaker Remote Follow-up Evaluation and Review (PREFER) Trial to Assess the Clinical Value of the Remote Pacemaker Interrogation in the Management of Pacemaker Patients. Chen, J; Wilkoff, BL; Choucair, W; Cohen, TJ; Crossley, et al.
http://www.ncbi.nlm.nih.gov/pubmed/18387185/

Complexity of MRI Induced Heating on Metallic Leads: Experimental Measurements of 374 Configurations

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Mattei, E; Triventi, M; Calcagnini, G; Kainz, W; Mendoza, G; Bassen, HI
Department of Technologies and Health, Italian National Institute of Health

PubMed

ABSTRACT
BACKGROUND: MRI induced heating on PM leads is a very complex issue. The widely varying results described in literature suggest that there are many factors that influence the degree of heating and that not always are adequately addressed by existing testing methods.

METHODS: We present a wide database of experimental measurements of the heating of metallic wires and PM leads in a 1.5 T RF coil. The aim of these measurements is to systematically quantify the contribution of some potential factors involved in the MRI induced heating: the length and the geometric structure of the lead; the implant location within the body and the lead path; the shape of the phantom used to simulate the human trunk and its relative position inside the RF coil.

RESULTS: We found that the several factors are the primary influence on heating at the tip. Closer locations of the leads to the edge of the phantom and to the edge of the coil produce maximum heating. The lead length is the other crucial factor, whereas the implant area does not seem to have a major role in the induced temperature increase. Also the lead structure and the geometry of the phantom revealed to be elements that can significantly modify the amount of heating.

CONCLUSION: Our findings highlight the factors that have significant effects on MRI induced heating of implanted wires and leads. These factors must be taken into account by those who plan to study or model MRI heating of implants. Also our data should help those who wish to develop guidelines for defining safe medical implants for MRI patients. In addition, our database of the entire set of measurements can help those who wish to validate their numerical models of implants that may be exposed to MRI systems.

Additional Information:

Complexity of MRI Induced Heating on Metallic Leads: Experimental Measurements of 374 Configurations. Mattei, E; Triventi, et al. Dept of Technologies and Health, Italian National Institute of Health. March 2008.
http://www.ncbi.nlm.nih.gov/pubmed/18315869/

Recently Recalled Devices

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To view, recently recalled devices, please visit the website listed under Additional Information below.

Additional Information:

Recently Recalled Devices
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm

KidNet

Focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units. To see recently submitted MedSun Neonatal and Pediatric Device Reports, see Neonatal and Pediatric Devices.

Joint Commission Journal on Quality and Patient Safety

The Joint Commission's latest Sentinel Event Alert addresses pediatric medication errors, and urges greater attention to precautions such as medication standardization, improved medication identification and communication techniques, as well as the use of kilograms as the standard weight measurement to calculate proper dosages. The article also provides other recommendations to reduce the risk of pediatric medication errors.

Additional Information:

Prevent Pediatric Medication Errors. Joint Commission Journal on Quality and Patient Safety. April 11, 2008.
http://www.jointcommission.org/NewsRoom/NewsReleases/nr_04_11_08.htm

Development, Testing, and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in U.S. Children’s Hospitals

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Takata, Glenn; Mason, Wilbert; Taketomo, Carol; Logsdon, Tina; Sharek, Paul
American Academy of Pediatrics

OBJECTIVES. The purposes of this study were to develop a pediatric-focused tool for adverse drug event detection and describe the incidence and characteristics of adverse drug events in children's hospitals identified by this tool.

METHODS. A pediatric-specific trigger tool for adverse drug event detection was developed and tested. Eighty patients from each site were randomly selected for retrospective chart review. All adverse drug events identified using the trigger tool were evaluated for severity, preventability, ability to mitigate, ability to identify the event earlier, and presence of associated occurrence report. Each trigger and the entire tool were evaluated for positive predictive value.

RESULTS. Review of 960 randomly selected charts from 12 children's hospitals revealed 2388 triggers (2.49 per patient) and 107 unique adverse drug events. Mean adverse drug event rates were 11.1 per 100 patients, 15.7 per 1000 patient-days, and 1.23 per 1000 medication doses. The positive predictive value of the trigger tool was 3.7%. Twenty-two percent of all adverse drug events were deemed preventable, 17.8% could have been identified earlier, and 16.8% could have been mitigated more effectively. Ninety-seven percent of the identified adverse drug events resulted in mild, temporary harm. Only 3.7% of adverse drug events were identified in existing hospital-based occurrence reports. The most common adverse drug events identified were pruritis and nausea, the most common medication classes causing adverse drug events were opioid analgesics and antibiotics, and the most common stages of the medication management process associated with preventable adverse drug events were monitoring and prescribing/ordering.

CONCLUSIONS. Adverse drug event rates in hospitalized children are substantially higher than previously described. Most adverse drug events resulted in temporary harm, and 22% were classified as preventable. Only 3.7% were identified by using traditional voluntary reporting methods. Our pediatric-focused trigger tool is effective at identifying adverse drug events in inpatient pediatric populations.

Additional Information:

Development, Testing, and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in U.S. Children’s Hospitals. Takata, Glenn; et al. American Academy of Pediatrics.Vol. 121, No. 4, April 2008.
http://pediatrics.aappublications.org/cgi/content/abstract/121/4/e927

Highlighted Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period March 1 through March 31. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

CARDIOVASCULAR

Device: monitor, physiological
Model# Dash 4000; Dash 3000; Solar 8000i
Manufacturer: GE Medical Systems Information Technologies
Problem: Dash 4000 monitor went blank while in use on patient. Dash 3000 monitor went blank while in use on patient. Solar 8000i monitor also made by GE failed to correctly detect patient's heart rate while in use.

Device: Defibrillator; M Series
Manufacturer: Zoll Medical Corporation
Problem: Patient with a near syncopal episode earlier, but no signs/symptoms at time of paramedic arrival. Pacer pads were placed on the patient, and staff were unable to pace. Patient had all four leads on, and each electrode had full contact with the patient's skin. All wires were properly hooked up to the monitor. All leads were in the appropriate spot/side and all leads (I, II, III, aVF, aVL and aVR) were showing the patient's rhythm on the defibrillator/monitor screen. The pads were also properly placed (anterior/posterior) and attached correctly at each junction. The monitor was put on "pacer" and the spikes that indicate the dialed rate (70) were noted in the monitor and the rate could be modified with the dial. When the mA dial was turned the monitor showed "0" and did not change when the dial was turned either way. The patient's rhythm did not change either and the patient denied feeling the "shocks" from being paced. Patient was transported to hospital as a "Code III" (emergency vs. routine) status due to the staff's concern that the patient's condition could deteriorate and the defibrillator would not work. There was no change in the patient's condition in route to the hospital. The defibrillator was removed from service and sent to Zoll for repair. Zoll reported that device is able to power up on battery and AC. The problem of being unable to adjust the pacer current was verified. The "Control to System Flex Cable" was reseated to remedy the problem condition. Software version 38.80 was installed. The device passed all final system level tests and was recertified to be used clinically.

Device: Lead, ICD; Sprint Quattro
Model# 6947
Manufacturer: Medtronic, Inc.
Problem: During ICD RV lead implant, RV lead became stuck at axillary/subclavian juncture. Medtronic called to assure MD that suture sleeve would not dislodge if lead pulled back. Assured by Medtronic. Physician pulled back lead and sleeve dislodged and lodged in lung tissue. At this time, Medtronic called back and said sleeve could dislodge. It was decided that there would be more harm if we attempted to remove sleeve so it remains lodged in the patient. Patient is aware. No harm to patient at this time.


GASTROENTEROLOGY/UROLOGY

Device: Hemodialysis Machine; Centry 3, C3+
Manufacturer: Gambro Renal Products, Inc.
Problem: During setup of the pH alarm on the Cobe/Gambro Centry C3+ dialysis machine, the machine alarmed "dialysate pH low." The biomed testing conclusion was that the problem was due to inadequately mixed bicarb solution.

Device: Dialysis Machine; Phoenix
Manufacturer: Gambro Renal Products, Inc.
Problem 1: Dialysis treatment delayed for alarm Concentrate Type Error A pump 40. Found mineral buildup on concentrate line connectors. Operating within manufacturer's guidelines after vinegar rinse.

Problem 2: Machine did not pull target weight and patient remained hypertensive after treatment. Required one dose of sublingual nifedipine.

Problem 3: Three problems at the beginning of the dialysis treatment: High level in UF vessel, # 144 Flow Balance error and #145 UF rate vessel. Treatment was stopped and reinitiated on another machine. No harm to patient.

Problem 4: Machine produced a dialysate flow error message. Operator may not have performed vinegar rinse prior to use.

Device: Catheter, Dilation; XXL
Model# XXL/12-4/5.8/75
Lot# 9794903 or 9794900
Catalog# M001145100
Other Device# 14-510
Manufacturer: Boston Scientific

Device: Stent, Biliary; Wallstent
Lot# 9441404
Catalog# H9654031100
Other Device# 40311
Manufacturer: Boston Scientific

Problem: Attempted placement of superior vena cava stent. The Wallstent was positioned in the SVC and deployed. The balloon was inflated to its rated burst pressure of 8 atmospheres. There was still a waist at the superior margin of the stent therefore the balloon was inflated to 10 atmospheres. As the pressure approached 10 the balloon ruptured. The patient went into full cardiac arrest and could not be resuscitated. Autopsy revealed a hemopericardium (300 cc's of liquid/clotted blood), immediate cause of death: Cardiac Tamponade.

The WALLSTENT Endoscopic Biliary Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms. For more information, visit:
http://www.bostonscientific.com/Device.bsci?navRelId=1000.1003&req_from_page=procedure&req_id=10000611&page=HCP_Overview&method=DevDetailHCP&id=10089521&pageDisclaimer=Disclaimer.ProductPage


GENERAL HOSPITAL

Device: Sterilizer, Scope, Universal Tray; Universal Flexible Processing Tray
Manufacturer: Steris Corporation
Problem: Urgent recall notice received for Steris System 1 processor. The alert necessitates a change in the way the c1160 tray accessory is used with the system 1 sterile processing system. Until further notice you must run a diagnostic after each cycle or you must discontinue use of these trays if this can't be done.

Device: Catheter, IV, Safety; Protectiv Plus; 18g 1-1/4"
Lot# 37H11SD02
Catalog# 3065
Manufacturer: Smiths Medical
Problem: Nurse completed IV catheter insertion. Upon disengaging device from catheter, needle was unable to fully retract and lock inside the protective chamber. Nurse sustained needle stick from dirty needle. When looking at the device, the back portion of the protection chamber is noticeably flattened instead of round. This change in shape prevented the needle from retracting and locking. The plastic material the device is manufactured from is not cracked or broken. It is unknown why the shape of the device is distorted. Smiths Medical was very concerned. After the incident was relayed to the sales rep, it was only about an hour and a half before their QA contacted the site. The QA person responded that she would be filing a report with the FDA. Smiths did ask for the catheter but until all of the testing for nurse's health is complete, we will not release. The rep did come by last week; she did look at the device. It is obvious by looking at the device that something is wrong with it. She saw the defect and commented that she did not know what happened. Smiths is welcome to come in and inspect the device in our lab.

Device: Pump, IV; Medfusion
Manufacturer: Smiths Medical
Problem: Possible underinfusion of IV medication indicated by patient response to drug being infused. Infusion pump was programmed to deliver body weight/concentration mode which is used by anesthesia. Nursing uses volume over time and rate mode, causing confusion to nurse operator and possibly induced programming error.

Device: Tubing, IV; LifeShield PlumSet
Manufacturer: Hospira Global Medical Affairs

Device: Drug Transducer Device, Closed System; PhaSeal
Manufacturer: Carmel Pharma Inc.
Problem: The RN met with resistance when trying to administer Doxorubicin with an attached Phaseal injector luer lock device. There is a question of incompatibility between the Hospira/ICU Medical IV clave and the Phaseal luer lock. Hospira says the clave is not compatible; PhaSeal has represented that it is. Additional problems our hospital has experienced with the PhaSeal:

1) syringe pump with the PhaSeal pieces does not sense or accept any syringes smaller than 20 cc’s which is a problem with the pediatric and neonate population;

2) we have had needle exposures due to incorrect use;

3) in a couple of situations our connector has broken the clave.

The manufacturer is working with the hospital to resolve these issues, some of which are education-related.

Device: Warmer, Infant; Air-Shields Infant Intensive Care System
Model# IICS-90
Manufacturer: Draeger Medical
Problem: Each infant warmer has a double cylinder holder mounted onto each unit. Plastic knobs with threaded screws hold E Oxygen cylinder tanks in place. The plastic knobs stick out, and 2 had become broken just by moving the warmers around in the storage room. When the plastic knob breaks, they break in such a manner that leaves very sharp edges. Two staff members had their fingers sliced by the sharp plastic, and therefore replaced the plastic knobs with different screws made strictly out of metal, with a flat end the user can grip to turn and tighten.

Device: Incubator, Infant; Isolette
Manufacturer: Draeger Medical
Problem: RN found neonate tachycardic, tachypneic and decreased saturations. Both baby and isolette were very warm. Was set on servo control but was found to be on air control, attempt to change but alarmed 'probe malfunction.' Unable to change to servo control. Had to turn bed off to decrease neonate's temp from 101.9. After temp decreased, attempt to turn bed back on was unsuccessful.

Device: Tubing, IV; Mini Loc Safety Infusion Set
Model# 0682234
Lot# asrhs002
Manufacturer: Bard Access Systems
Problem: A total of 5 of these 90 degree angle infusaport access needles broke off from the attached extension set.


ANESTHESIOLOGY

Device: Ventilator; Servo I
Manufacturer: Maquet, Inc.
Problem: Servo Ventilator went into Non-Functioning failure mode with screen display saying: technical error 25, 33, etc. Brought unit to Biomed and checked log to confirm errors. Screen shows solid technical error 33 in red. Log shows various technical errors including, technical error 10, 11, 12, 16, 25, 33 and 35. Will place call to Maquet for service. The investigation performed by Maquet shows heavy oxidation and stains from fluids on the PC boards (PC1771, PC1772, PC1781 and PC1784). This was caused by fluid entering the device on several occasions. The source of the fluid and how it entered the device cannot be determined. Alarms were generated by the device during the event. The cause of error codes in the error log are short circuits at several places due to heavy oxidation. No further actions are being taken by Maquet at this time. Based on the above information Maquet considers this complaint closed. Maquet will add the investigation information to their complaint database and will monitor for trends.

Device: Suction, Endotracheal; Ballard Trach Care
Model# 198
Manufacturer: Kimberly-Clark Corporation
Problem: NICU infant was being suctioned by RN. Suction catheter broke off inside of the patient's endotracheal tube. RN had to cut the plastic covering to retrieve the broken catheter from the infant's endotracheal tube.

Device: Suction, Endotracheal; Ballard Trach Care-Y-adapter
Model# 198
Manufacturer: Kimberly-Clark Corporation
Problem: Eight french closed suction system being used to suction the endotracheal tube of an infant in the NICU. The suction control port was compressed to activate the suction, and it stuck in the on position. RN was unable to relieve the suction or disengage the port. Device was removed from the patient and replaced with new device of same type without further incidence.


GENERAL & PLASTIC SURGERY

Device: Razor, Surgical Prep; Shave Prep Comb/Comb
Model# Item 139083
Manufacturer: Covidien Kendall
Problem: The Kendall brand prep razor is a new product at this facility. Many staff members have reported difficulties with safely removing the clear plastic protective caps that cover the razor's edges. There are two arrows embossed on the top of the razor which are located adjacent to the words "Side A", and point downwards to Side A. Two injured staff members explained that they believed the arrows pointed to where on the razor their fingers should be placed in order to remove the protective cover. However, the arrows are in place to indicate which side of the razor is "Side A" of the double-bladed razor edge. Two injuries have resulted so far due to staff members placing their fingers on the blade side of the razor to remove the cover. One staff member received a laceration of the finger that required suturing, while another staff member received an avulsion of a portion of the finger pad. Surgigel was used to repair the avulsion, and both employees missed some of their scheduled shifts because of these injuries. Of note, to safely remove the protective cover, the cover is to be gripped on the short sides of the razor (not "Side A") and pulled upward to remove the cover. Additional educational materials for this product was requested from the manufacturer, however, it has been learned that there are no instructions available on how to safely remove the cover.

(Note from FDA: Good example of Human Factors issues seen with medical devices).

Device: Arm, Robotic Device; da Vinci Robot Endoscopic Instrument Control System
Model# PS2000
Manufacturer: Intuitive Surgical, Inc.
Problem: Physician was using Intuitive da Vinci robot when camera arm stopped working during a case and listed non-recoverable error 23020 fault. Camera arm was replaced next day with a re-manufactured arm and tested by Intuitive engineer. Same arm failed again just prior to the start of next scheduled case. Engineer replaced a second camera arm. As a precaution, two other robotic arms where replaced to match software version of the third.

======================
Manufacturer response for da Vinci Robot Endoscopic Instrument Control System
Manufacturer was sympathetic and regretted circumstances surrounding robot arm failing twice in a row. Manufacturer offered to add hospital to their “customer care plan”, which is designed to increase customer confidence by having service engineer download machine values after each use. In theory, downloaded values will identify issues prior to them happening.


OPTHALAMIC

Device: Lens Injector; Monarch IOL Delivery System
Model# SN60WF IOL
Manufacturer: Alcon Laboratories, Inc.
Problem: Ophthalmologist performed two cataract surgeries at one of our sister facilities. Procedure went well until following lens implantation; a small tear was noted at juncture of optic and haptic. Surgeon decided to leave lens implanted as little risk of short or long term vision problem. Both patients remain doing well. Alcon rep was contacted, and investigated immediately. Decision was that injector used did not match the shooter. Surgeons had been unaware of this. Decision to remove purple injectors from ORs across the system was made and accomplished. Educational issue may involve other institutions. Alcon rep informed, and immediately investigated. Findings: No defective device, found mismatch in injector and cartridge. Advised removal of all purple injectors from system. This was done immediately. Appropriate color match replaced.

Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Cranial Perforators

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Over the past 5 years, MedSun has received 15 adverse event reports associated with the perforator device manufactured by Codman and Shurtleff, Inc., Acra-Cut, Inc., and Stryker Instruments. The reports were submitted by 9 hospitals between September 2003 and April 2008. The most frequently reported device problems were (please note, several problems are often reported in one report):
•14 events where the perforator did not stop as expected
•1 event where the perforator stopped halfway through the skull, re-started again and then would not stop.

There are no MedSun reports involving a patient death during this time period. The most frequently reported patient problems are:

•6 events where an injury to the patient’s dura resulted
•1 event where a perforated dura and brain bruise resulted

Of the reports that listed patient age, 4 had a patient age listed as less than 21 years and 10 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 9 reports involved female patients and a total of 4 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. The FDA is interested in hearing from other facilities that may have experienced similar problems with this device.

The purpose of providing this summary, and the following reports, is to inform you about problems reported to FDA by the MedSun clinical community. These, as well as non-MedSun reported problems involving this device may also be investigated by searching FDA’s on-line MAUDE database available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

CRANIALPERFORATOR

Device	Device Identifiers	Event Description
Acra-Cut Inc. Cranial Perforator	Model DGR-1 200-241 Other# 14/11mmR Lot # 6288	The Acra Cut perforator didn't stop once it hit the inner cortex of bone, the clutch did not disengage. The doctor pulled back before it hit the dura. No patient injury or harm. Concern the perforator did not perform as attended.
Acra-Cut Inc. Cranial Perforator	Model DRG-0 200-271 Lot # 6280	When using the drill the perforator did not stop turning when it got past bone.
Acra-Cut Inc. Cranial Perforator	Model DGR-I 200-243 Other # 6517	The Acra Cut perforator didn't stop once it hit the inner cortex of bone. No apparent injury to the patient and didn't go through the dura.
Codman and Shurtleff, Inc. Cranium perforator Disposable perforator	Model# 14mm Lot # EZ892 catalog# 26-1221	Case was a VP shunt revision, when MD was using perforator it stopped halfway through skull, restarted and then the perforator did not stop and MD had to pull the perforator out of the skull to prevent brain damage.
Codman and Shurtleff, Inc. Cranium perforator Disposable perforator	Model # 26-1221 Lot # EZ892	MD was using perforator for this case. After drilling first couple of holes, on the sixth hole the perforator failed to stop.
Stryker Instruments Drill Driver ACRA-CUT, INC, bit perforator	Drill Driver Model PD series 5400-210 bit, perforator DRG-O 200-271 Lot #5697	A perforator bit failed during an operation in the main OR. When perforating the patient's skull, the surgeon stated that the bit did not stop rotating once it had pierced the skull. In normal operation, the bit rotates only when pressed against a hard surface (skull). The driver and bit were delivered to Biomedical Engineering for examination. At that time, a request was made by Biomed for sterilization of the parts involved (the bit, drill driver, and hose). The bit was lost during the sterilization process. The bits are disposable and intended for one time use. It was later recovered. A Stryker rep later examined the driver and was certain that the device functioned normally. The supply chain manager is in the process of contacting the manufacturer of the bit, ACRA-CUT.
Codman and Shurtleff, Inc. Disposable Perforator	(14mm) Lot MX824 Ref #26-1221	Neurosurgeon requested that event be reported. A disposable perforator malfunctioned during procedure, causing a perforation of the dura.
ACRA-CUT, Inc. Cranial Perforator	Model DGR-0 200-271	When drilling burr hole in patient's skull, perforator did not stop as designed penetrating dura.
Codman and Shurtleff, Inc, Disposable Perforator	(14mm) Model 26-1221 Lot # GX851 Catalog # 26-1221	A surgeon was using a Codman 14mm Disposable perforator to enter the brain. The perforator did not stop when it was supposed to causing the drill to enter the dura.
ACRA-CUT Inc. Cranial Perforator	Model DRG-0 200-271	A 14 mm. Acracut perforator failed to stop during perforation of skull after passing through bone matter. The perforator went through the dura layer and bruised a small area of brain.
ACRA- CUT, Inc. Cranial Perforator with Hudson end	Model 200-271 Lot # 4905	The initial perforator clutch stop did not function and, as a result, the second safety backup prevented rotation of the perforator when skull penetration occurred. The event did not cause harm to the patient. The manufacturer was notified of the malfunction.
ACRA-CUT, Inc. Cranial perforator	Model # DGR-0 Lot # 4905	Disposable cranial perforator did not disengage and caused a dural tear.
Codman and Shurtleff, Inc,	Perforator	The perforator did not stop once the burr hole was accomplished. It perforated the dura but not the brain.
ACRA-CUT, Inc. Disposable Cranial Perforator	Model: DRG-II 200-253 Cataolg: Mini 11/7mmR	The Acra Cut perforator didn't stop once it hit the inner cortex of bone. The perforator nicked the dura.
ACRA-CUT, Inc.	Model: 200-253 Cataolg: Mini 11/7mmR	The Acra Cut perforator didn't stop once it hit the inner cortex of bone. The perforator nicked the dura.

Additional Information:

FDA’s on-line MAUDE database available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

Summary of MedSun Reports Describing Adverse Events With High Frequency Oscillatory Ventilators

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Over the past 2 years, MedSun has received 8 adverse event reports associated with the High Frequency Oscillatory Ventilator device manufactured by SensorMedics/Viasys/Cardinal Health. The reports were submitted by 6 hospitals between July 2006 and January 2008. The most frequently reported device problems were (please note, several problems are often reported in one report):
•5 events where the ventilator stopped or lost power
•1 event where the driver module stopped
•1 event where the diaphragm was stuck
•1 event where the ventilator settings were drifting


Of the reports that listed patient age, two had a patient age listed as less than 21 years and five had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of three reports involved female patients and a total of four reports involved male patients.

These MedSun reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.

The purpose of providing this summary, and the following reports, is to inform you about problems reported to FDA by the MedSun clinical community. These, as well as non-MedSun reported problems involving this device may also be investigated by searching FDA’s on-line MAUDE database available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

High Frequency Oscillatory Ventilator

Device	Device Identifiers	Event Description
Ventilator, High Frequency Oscillator	3100B	Oscillator stopped while in use. Respiratory therapist and RNs bagged patient and attempted to troubleshoot equipment w/o success. Device removed from use. BioMed Dept tested w/ initial circuit setup; tech unable to get airway pressure with provided setup. Replaced pt circuit w/ new circuit. Unit ran 12 hrs over course of 2 days w/o problem, holding correct airway pressure. 2000hr PM and calibration done as precaution and device returned to service.
Ventilator, High Frequency Oscillator	3100A	The nurse noted that the ventilator (vent) suddenly stopped. The nurse immediately began bagging the patient and summoned RT who was on the unit. Per RT, it was hard to restart the ventilator. Within the hour, the oscillator ventilator lost power and stopped again. The vent alarmed appropriately and the patient was immediately placed on another vent. Cardinal/Viasys was notified and a trouble ticket and complaint were issued for evaluation and repair of the ventilator. Cardinal did note that the machine would be due for its 7 year preventative maintenance (PM), Driver Power Module replacement this year. There was no adverse effects to the patient. The current hour meter reading was 10398. Settings were flow 25 lpm, Insp% 33, pressure limits low 18 cm H2O and high 35 cm H2O. Vent alarm settings low 18 cm H2O and high 35 cm H2O. Vent monitored readings were fiO2 0.62, MAP 21 cm H2O nad amplitude 54 cm H2O. Last service was 32 months ago by Viasys. The unit hour meter reading was 4640.
Ventilator, High Frequency Oscillator	3100B	Patient on High Frequency Oscillating Ventilator (HFOV) when the Ventilator stopped oscillating, the nurse was in the room and immediately started to bag. Patient never desaturated, and was by all accounts fine. The driver assembly just stopped on this 3100B oscillator. The oscillator does not have onboard diagnostics or error code logs or even user alarm logs.
Ventilator, High Frequency Oscillator	3100B	The respiratory therapist reports that the ventilator settings were drifting. "On each ventilator check the knobs were being turned a little to obtain the original settings. The settings were set as follows: mean airway pressure (MAP) 32, amplitude (Delta P) 75, frequency (Freq) 4, and O2 100%. The ventilator was checked per protocol and the ventilator settings were as follows: MAP 21, Delta P 92, Freq 0.6, and O2 60%. The arterial blood gases (ABG's) were poor to begin with, they had become slightly worse but returned to baseline once the ventilator was changed out.
Ventilator, High Frequency Oscillator	3100B	Upon turning on the oscillator, it shut down spontaneously. Three more attempts to start the oscillator resulted in automatic shut down. Providers noticed a burning smell coming form the oscillator which was replaced with a new unit. The patient was not harmed.
Ventilator, High Frequency Oscillator	3100A	Cardiac monitor was attached to patient and running efficiently. Nurse at bedside noticed that oscillator spontaneously shut itself off. No alarms sounded, and Mean Arterial Pressure read -22. Manual resuscitation of patient was initiated. Lights for restart button and 45 second silence did not display. Respiratory therapist arrived, troubleshoot routine started: check for leaks, used battery back-up. No response from machine. Representative was called. Replacement machine sent.
Ventilator, High Frequency Oscillator	3100B	The High Frequency Oscillatory Ventilator 3100B started to make odd, loud noises. The diaphragm appeared to be getting stuck. The ventilator was changed at that time. In switching the ventilator out, the patient had a slight oxygen desaturation. He quickly recovered to the state he was in previous to the incident.
Ventilator, High Frequency Oscillator	3100B	Patient on 3100B Oscillatory Ventilator that failed. Manual ventilation was initiated without any patient compromise. New ventilator was set up.

Additional Information:

FDA’s on-line MAUDE database available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

Updated June 1, 2008