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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 11/10/2003
Event Type  Malfunction  
Event Description

The baxter technician reported an infusion pump with an 810:04 failure code that occurred during service. 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

Evaluation summary: the reported condition of failure code 810:04 was confirmed.

 
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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 Key486639
MDR Report Key497892
Event Key472104
Report Number6000001-2003-09268
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2003
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? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/10/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2001
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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