BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 496105 · Received November 12, 2003

    Report

    Report Number
    6000001-2003-09234
    Event Type
    Malfunction
    Date Received
    November 12, 2003
    Date of Event
    November 3, 2003
    Report Date
    November 7, 2003
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSION PUMP WITH A 12:303:984:0002 FAILURE CODE. THE FACILITY'S REP STATED THAT NO PT INCIDENTS WERE REPORTED ON THIS PUMP SINCE THE LAST BAXTER SERVICE EVENT. IT IS NOT KNOWN IF THE FAILURE OCCURRED WHILE INFUSING ON A PT. INFO REGARDING PT DEMOGRAPHICS, MEDICATION INVOLVED AND DEVICE PROGRAMMING WAS REQUESTED BUT NONE WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN