BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1024014 · Received April 5, 2008

    Report

    Report Number
    6000001-2007-04247
    Event Type
    Malfunction
    Date Received
    April 5, 2008
    Date of Event
    January 19, 2007
    Report Date
    January 19, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-7/20/05-015-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: EVALUATION WAS PERFORMED. FAILURE CODE 703:00 ON CHANNEL C WAS FOUND IN THE EVENT HISTORY OF THE DEVICE. INSPECTION OF THE PUMP FOUND IN THE EVENT HISTORY OF THE DEVICE. INSPECTION OF THE PUMP REVEALED DEFECTIVE USER INTERFACE MODULE PRINTER CIRCUIT BOARD (UIM PCB) WAS DUE TO FAILURE CODE 703:00. THE UIM PCB WAS REPLACED. THE PUMP WAS TESTED FOR PROPER OPERATION AND PUMP FOUND TO FUNCTION PROPERLY.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, DEFECTIVE USER INTERFACE MODULE PRINTER CIRCUIT BOARD (UIM PCB) WAS FOUND. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION OR CONTACT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1