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Adverse Event Report

BAXTER/SABRATEK CORP. SABRATEK 6060 HOMERUN PUMP SABRATEK 6060 PUMP   back to search results
Catalog Number 2M9832
Event Date 05/01/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

A patient was receiving fentanyl (20 ug/ml, 100 ml bag, intraveneous infusion) via a 6060 pump in the pca mode. At 1400 on the day of the event, the nurse changed the bag. The infusion was started. The nurse came into the room at 1430 for another reason, and the patient "seemed fine". At 1500, the patient's spouse called the nurse into the room, where it was discovered that the pump had a constant "malfunction 9" alarm, and the entire bag of fentanyl had been infused. The set-up was checked, and no leakage was found. Narcan was administered to the patient, and was sent to the surgical icu. As far as the reporter of this incident knows, the patient has returned to pre-incident status.

 
Manufacturer Narrative

Preliminary evaluation of the pump indicated that a brass boss on the back of the pump had been broken off, causing conductive flaking to "float around" inside the pump, and to possibly touch the pump's circuitry. The evaluation has not been completed. Should additional significant information become available, a follow-up report will be submitted.

 
Manufacturer Narrative

Visual inspection of the pump revealed that the brass boss on the back of the pump had been broken off, causing conductive flaking to float around inside the pump. With the condition of hte pump, operational results cannot be predicted. Pieces of conductive plastic, especially pieces as large as the boss, rattling around inside an electronic piece of equipment have the potential for problematic and irreproducible behavior. The cause of the conductive plastic pieces inside the pump was clearly concluded to be the breakage of the boss. The breakage is in turn caused by the unauthorized reengineering of the mounting of the pump to the lockbox. The acount has been advised to terminate their method for mounting the pump in the lockbox, thus preventing the conductive pieces from being created in the first place.

 
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Brand NameSABRATEK 6060 HOMERUN PUMP
Type of DeviceSABRATEK 6060 PUMP
Baseline Brand NameSABRATEK 6060 HOMERUN PUMP
Baseline Generic NameSABRATEK 6060 PUMP
Baseline Catalogue Number2M9832
Baseline Model Number2M9832
Baseline Device FamilySABRATEK 6060 PUMP
Baseline Device 510(K) NumberK941984
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/01/1995
Manufacturer (Section F)
BAXTER/SABRATEK CORP.
8111 n. st. louis ave.
skokie IL 60076
Manufacturer (Section D)
BAXTER/SABRATEK CORP.
8111 n. st. louis ave.
skokie IL 60076
Manufacturer Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key334544
MDR Report Key345212
Event Key325096
Report Number6000001-2001-00347
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/10/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2M9832
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/11/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/1996
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on January 30, 2009

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