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Adverse Event Report

BAXTER HEALTHCARE (SG) COLLEAGUE VOLUMETRIC INFUSION PUMP   back to search results
Model Number COLLEAGUE
Event Date 12/06/2002
Event Type  Malfunction  
Event Description

The facility's biomed reported an infusion pump with a 500 failure code. The biomed stated they have no record of any pt incident involving the pump since the last baxter service event.

 
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

Evaluation summary: the customer's reported condition of failure code 500 was confirmed. The information provided and the results from testing indicate the root cause to be a defective front bezel main keypad.

 
Search Alerts/Recalls

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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 FamilyLARGE VOLUME INFUSION PUMP, COLLEAGUE
Baseline Device 510(K) NumberK953098
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed07/07/1997
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 Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key422670
MDR Report Key433731
Event Key410408
Report Number6000001-2002-06424
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/06/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2002
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 Manufacturer12/06/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/06/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2000
Is The Device Single Use? 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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