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Adverse Event Report

BAXTER HEALTHCARE (SG) COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP   back to search results
Model Number COLLEAGUE 3
Event Date 11/01/2002
Event Type  Malfunction  
Event Description

The facility's biomed engineer reported an infusion pump with an 812:02 failure code which occurred during pt use. The biomed stated that it was unknown if there have been any reports of any pt incident involving the pump since the last baxter service event. Info was requested by baxter regarding specific pt info, whether or not there was a report of medical intervention or pt injury, pump programming and set-up info, tubing product code and lot number in use and the medication involved if applicable, but no additional info was available. Additional contact info was requested but not provided.

 
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. This report represents all info known by the reporter at this time.

 
Manufacturer Narrative

Eval summary: the customer reported condition of failure code 812:02 was confirmed. Testing indicate the root cause is a damaged gear on the pumphead gearbox and the chassis front plate screws are too tight.

 
Search Alerts/Recalls

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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
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 rd
round lake , IL 60073
(847) 270 -4696
Device Event Key503953
MDR Report Key514944
Event Key488549
Report Number6000001-2002-07006
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/29/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2002
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 Manufacturer12/03/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/29/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1998
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 February 28, 2009

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