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Adverse Event Report

BAXTER HEALTHCARE (SG) COLLEAGUE 3 VOLUMETRIC INFUSION PUMP   back to search results
Model Number 2M8153
Event Date 04/20/2001
Event Type  Malfunction  
Event Description

Biomed received a vague incident report stating iv ran wide open and gave 80cc of fluid when set to give only 4cc. Attempts were made to obtain additional information from the reporting facility and details were not available regarding patient information, medication involved, or flow rates device was set to. No patient injury or medical intervention was reported during discussion with the hospital staff.

 
Manufacturer Narrative

Evaluation summary: the infusion pump was tested for flow accuracy at 100 ml/hr and 10 ml/hr. The results were within specification.

 
Search Alerts/Recalls

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Brand NameCOLLEAGUE 3 VOLUMETRIC INFUSION PUMP
Type of DeviceINFUSION PUMP
Baseline Brand NameCOLLEAGUE VOLUMETRIC PUMP
Baseline Generic NameINFUSION PUMP
Baseline Catalogue Number2M8153
Baseline Device FamilyCOLLEAGUE VOLUMETRIC PUMP
Baseline Device 510(K) Number
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 (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 Key336240
MDR Report Key346937
Event Key326718
Report Number6000001-2001-00354
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 07/09/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2M8153
Device Catalogue Number2M8153
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/11/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2001
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2001
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 December 31, 2008

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