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Adverse Event Report

BAXTER HEALTHCARE (SG) COLLEAGUE VOLUMETRIC INFUSION PUMP   back to search results
Model Number COLLEAGUE
Event Date 08/01/2001
Event Type  Malfunction  
Event Description

The pump was returned to baxter's service center with no condition reported. The pump arrived with all wires and batteries disconnected. The pump was reassembled and found to turn on/off by itself. The pump was not pumping at the time. Attempts were made to gather add'l info from the customer but no add'l info is available at this time.

 
Manufacturer Narrative

The pump is in the process of being evaluated. A follow up report will be filed upon completion of the eval or if any add'l details become available.

 
Manufacturer Narrative

Evaluation summary: operational tests were performed and the report of the device spontaneously turning on and off was observed. During visual inspection, the keypad flex cable was found to be discolored. The reported condition may be related to the issue of keypad flex cable degrading which causes an intermittent short circuit. As a result, an unexpected power "on/off" cycling of the pump can occur without a key press. The keypad will be replaced and tested prior to being returned to the customer.

 
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 indust. park d
singapore
SINGAPORE SG 738750
Manufacturer (Section D)
BAXTER HEALTHCARE (SG)
2 woodlands indust. park d
singapore
SINGAPORE SG 738750
Manufacturer Contact
joanne celba
route 120 and wilson rd
round lake , IL 60073
(847) 270 -4696
Device Event Key351157
MDR Report Key362004
Event Key341258
Report Number6000001-2001-00526
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation UNKNOWN
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/22/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberCOLLEAGUE
Device Catalogue Number2M8153
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/22/2001
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received08/22/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/1999
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse
Removal/Correction Number6000001-1/112002-001-C

Database last updated on January 30, 2009

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