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Adverse Event Report

BAXTER HEALTHCARE (SG) COLLEAGUE VOLUMETRIC INFUSION PUMP   back to search results
Model Number COLLEAGUE
Event Date 01/01/2003
Event Type  Malfunction  
Event Description

The facility's technician reported an infusion pump with an 812:02 failure code. The technician stated that there has been no report of any pt incident involving this pump since the last baxter service event. Info was requested by baxter regarding whether or not the incident occurred during pt use or during biomed testing, but no additional info was available. Additional contact info was requested but no additional contact was identified.

 
Manufacturer Narrative

The pump has not been received. Should the pump become available for evaluation, a follow-up report will be filed upon completion of an evaluation or if any additional info becomes available.

 
Manufacturer Narrative

Evaluation summary: the customer reported condition of failure code 812:02 was confirmed. Inspection of the device revealed the root cause is a damaged gear in the pump channel gearbox.

 
Search Alerts/Recalls

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Brand NameCOLLEAGUE VOLUMETRIC INFUSION PUMP
Type of DeviceINFUSION PUMP
Baseline Brand NameCOLLEAGUE VOLUMETRIC INFUSION PUMP
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number2M8151
Baseline Model NumberCOLLEAGUE
Baseline Device FamilyLARGE VOLUME INFUSION PUMP, COLLEAGUE
Baseline Device 510(K) NumberK953098
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/07/1997
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 (Section G)
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 Key471989
MDR Report Key483098
Event Key457956
Report Number6000001-2003-00362
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/07/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberCOLLEAGUE
Device Catalogue Number2M8151
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/07/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/1998
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on January 30, 2009

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