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Adverse Event Report

BAXTER HEALTHCARE (SG) COLLEAGUE 3 VOLUMETRIC INFUSION PUMP   back to search results
Model Number COLLEAGUE 3
Event Date 12/01/2001
Event Type  Malfunction  
Event Description

The pump was returned for servicing with a report from a nurse that the pump turns off by itself. The pump was returned to biomed who tested the pump and was unable to confirm the report so the biomed returned the pump to the floor for use on patient's. The following day, the pump was returned to biomed with the same report. No patient injury resulted.

 
Manufacturer Narrative

The pump is in the process of being evaluated. A follow-up report will be filed upon completion of the evaluation or if any additional details become available.

 
Manufacturer Narrative

Evaluation summary: operational tests were performed and the report of the device spontaneously turning off was not observed. The event history ws reviewed and found no on/off cycling. The keypad was tested for proper operation and all keys were found to unction poperly. The reported conditon may be related to the issue of keypad flex cable degrading which causes an intermittent short ciucuit. As a result, an unexpected power "on/off" cycling of the pump can occur without a key press. The keypad will be replaced and tested prior to being returned to the customer.

 
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Brand NameCOLLEAGUE 3 VOLUMETRIC INFUSION PUMP
Type of DeviceINFUSION PUMP
Baseline Brand NameCOLLEAGUE 3 VOLUMETRIC INFUSION PUMP
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number2M8151K
Baseline Model NumberCOLLEAGUE 3
Baseline Device FamilyCOLLEAGUE VOLUMETRIC PUMP
Baseline Device 510(K) NumberK961703
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/01/1998
Manufacturer (Section F)
BAXTER HEALTHCARE (SG)
2 woodlands industrial park d
singapore
SENEGAL 738750
Manufacturer (Section D)
BAXTER HEALTHCARE (SG)
2 woodlands industrial park d
singapore
SENEGAL 738750
Manufacturer Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key362473
MDR Report Key373366
Event Key352257
Report Number6000001-2002-00037
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/17/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberCOLLEAGUE 3
Device Catalogue Number2M8153
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/17/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/17/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/1998
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
Removal/Correction Number6000001-1/112002-001-C

Database last updated on December 31, 2008

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