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Adverse Event Report

BAXTER HEALTHCARE PTE. LTD. COLLEAGUE 3 VOLUMETRIC INFUSION PUMP   back to search results
Model Number COLLEAGUE 3
Event Date 11/01/2003
Event Type  Malfunction  
Event Description

The facility reported a fail code 810:11. The hospital representative stated that there have been no reports of any patient incident involving this pump since the last baxter service event.

 
Manufacturer Narrative

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

 
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 PTE. LTD.
2 woodlands industrial park d
singapore
SINGAPORE 2573
Manufacturer (Section D)
BAXTER HEALTHCARE PTE. LTD.
2 woodlands industrial park d
singapore
SINGAPORE 2573
Manufacturer (Section G)
BAXTER HEALTHCARE PTE. LTD.
2 woodlands industrial park d
singapore
SINGAPORE 2573
Manufacturer Contact
peggi householder, rn bsn
route 120 & wilson road
round lake , IL 60073
(847) 270 -2999
Device Event Key486662
MDR Report Key497915
Event Key472127
Report Number6000001-2003-09286
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type User facility
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 11/14/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/20/2003
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? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/14/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/01/1998
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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