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Adverse Event Report

BAXTER HEALTHCARE (SG) PCA II PUMP ANESTHESIA PUMP   back to search results
Catalog Number 2L3104
Event Date 10/15/2001
Event Type  Malfunction   Patient Outcome  Required Intervention;
Manufacturer Narrative

The complaint condition was not confirmed. The unit met all performance specifications. There was no retained history in the pump. Therefore, the pump was evaluated in the pca/basal mode with a dose 1. 0 ml, delay 3 minutes, basal rate 3. 0 ml/hr, 1-hour limit 7 ml. The customer cable was used. The test was expected to deliver 9 ml (0. 6372" displacement), and actually delivered 9 ml (0. 635" displacement), which is equal to an error of -0. 35%.

 
Event Description

A pt was admitted to the hosp in 2001 for right hip pain, and was placed on a pcaii pump with morphine for pain control. Two days later, the pt was to be discharged, but the pt fell and fractured right hip. The pt was put on traction. Two days later at 8pm, the pt was found to be lethargic; and at 11pm, the pt was found to be unresponsive and twitching, which was thought to be a pre-existing condition that was exacerbated by the decrease of consiousness. At that point, the pt was sent to the icu. It is unknown what medical intervention took place other than sending the pt to the icu. Three days later, the biomed downloaded the history and printed it, and found that the only history in the pump was for two days ago. All previous history had been cleared. The programming of the pump is unknown. The dr's order was 2 mg every 10 minutes per the pt's file. The dr on the case did not know definitively what caused the episode, but had deemed it a hypoxic episide. The account did not know for sure if the pt had been overinfused or not.

 
Manufacturer Narrative

Although the pump has been requested for eval, it has not been received. Should further significant info become available, a follow-up report will be submitted.

 
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Brand NamePCA II PUMP
Type of DeviceANESTHESIA PUMP
Baseline Brand NamePCA II PUMP
Baseline Generic NamePCA PUMP
Baseline Catalogue NumberNA
Baseline Model Number2L3104
Baseline Device FamilyPCA II PUMPS
Baseline Device 510(K) NumberK921994
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed01/01/1989
Manufacturer (Section F)
BAXTER HEALTHCARE (SG)
2 woodlands industrial park d
singapore
SINGAPORE SG 738750
Manufacturer (Section D)
BAXTER HEALTHCARE (SG)
2 woodlands industrial park d
singapore
SINGAPORE SG 738750
Manufacturer Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key351354
MDR Report Key362200
Event Key341454
Report Number6000001-2001-00496
Device Sequence Number1
Product CodeMEA
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/19/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2L3104
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/15/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/19/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/1996
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 February 28, 2009

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