BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    MDR report key: 1150132 · Received August 29, 2008

    Report

    Report Number
    6000001-2008-00510
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVAL, OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A DEVICE THAT WAS INFUSING HEPARIN, AMINODARONE, AND NORMAL SALINE (RATE/DOSE, UNK AT THIS TIME) WHEN CHANNEL A READ "CLOSE SIDE CHANNEL". THE NURSE CLOSED THE SIDE CHANNEL AND THE PUMP KEPT ALARMING. THE NURSE ATTEMPTED TO SHUT OFF THE DEVICE AND THE DEVICE WOULD NOT SHUT OFF. THE NURSE SWITCHED THE PT TO A DIFFERENT PUMP. THERE WAS NO MEDICAL INJURY OR INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1