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Adverse Event Report

BAXTER HEALTHCARE PTE. LTD. COLLEAGUE VOLUMETRIC INFUSION PUMP   back to search results
Model Number COLLEAGUE
Event Date 02/13/2004
Event Type  Malfunction  
Event Description

The facility reported an infusion pump that turns on and off by itself. The hosp rep stated they have no record of any pt incident since the last baxter svc event.

 
Manufacturer Narrative

The pump is in the process of being evaluated. A follow-up report will be submitted upon completion of the eval, or if any add'l info becomes available.

 
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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 510(K) Number
Baseline Device PMA Number
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
jenny baethke, assistant mgr.
route 120 & wilson road
round lake , IL 60073
(847) 270 -6496
Device Event Key521190
MDR Report Key531941
Event Key505007
Report Number6000001-2004-00399
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type User facility
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 02/13/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2004
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? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2004
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/13/2004
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/01/2001
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 February 28, 2009

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