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Adverse Event Report

BAXTER HEALTHCARE PTE. LTD. COLLEAGUE CX VOLUMETRIC INFUSION PUMP   back to search results
Model Number COLLEAGUE CX
Event Date 02/03/2004
Event Type  Malfunction  
Event Description

The facility reported a fail code 810:04. Info was not provided regarding whether or not the failure occurred during an infusion. Although attempts were made by baxter, details were not available regarding add'l contact info, pt demographics, medication involved, or pump programming. The hosp rep stated that there have been no reports of any pt incident involving this pump since the last baxter service event.

 
Manufacturer Narrative

The pump has not been rec'd. Should the pump become rec'd for eval, a follow-up report will be filed upon completion of an eval or if any add'l info becomes available.

 
Search Alerts/Recalls

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Brand NameCOLLEAGUE CX VOLUMETRIC INFUSION PUMP
Type of DeviceINFUSION PUMP
Baseline Brand NameCOLLEAGUE CX VOLUMETRIC INFUSION PUMP
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number2M8161
Baseline Model NumberCOLLEAGUE CX
Baseline Device FamilyCOLLEAGUE VOLUMETRIC PUMP
Baseline Device 510(K) NumberK010566
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/01/2001
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 Key511646
MDR Report Key522516
Event Key495891
Report Number6000001-2004-00184
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/04/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberCOLLEAGUE CX
Device Catalogue Number2M8161
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2004
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/2001
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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