BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1241522 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-04572
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 31, 2007
    Report Date
    January 31, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS OBSERVED. THE FAILURE CODE 532, WHICH RESULTED ON DEVICE STARTUP CONFIRMS THE DEFECTIVE UIM PCB. THE UIM PCB WAS REPLACED AND THE DEVICE WAS TESTED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO BAXTER FOR SERVICE. DURING TESTING, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH A DEFECTIVE USER INTERFACE MECHANISM PRINTED CIRCUIT BOARD (UIM PCB). ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED RELATED TO THIS DEVICE. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1