BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1023163 · Received April 3, 2008

    Report

    Report Number
    6000001-2007-00491
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 11, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE EVALUATION WAS COMPLETED AND FAILURE CODE 570:320:844:000 (IN EVENT HISTORY), FOUND TO BE DUE TO A DAMAGED BATTERY CONDITION (10 ALARMS BELOW THRESHOLD), WAS CONFIRMED. SERVICE INSTALLED NEW BATTERIES AND TESTED THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT AND THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED FOR SERVICE (PREVENTIVE MAINTENANCE). DURING SERVICE TESTING, FAILURE CODE 570:320:844:0000 (DAMAGED BATTERIES) WAS FOUND IN THE EVENT HISTORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1