BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP

    MDR report key: 1021534 · Received March 26, 2008

    Report

    Report Number
    6000001-2008-00193
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REC'D FOR EVAL. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE EVAL, OR IF ANY ADD'L DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE RPTR AT THIS TIME.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED A PUMP THAT KEEPS ALARMING AND WILL NOT RUN. THIS WAS FOUND DURING BIO-MED TESTING, WITH NO PT INVOLVEMENT. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAILABLE REGARDING ADD'L CONTACT INFO. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP 80FRN FRN BAXTER HEALTHCARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1