BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR PUMP

    MDR report key: 1081876 · Received July 21, 2008

    Report

    Report Number
    6000001-2008-00428
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED THE PUMP INTERMITTENTLY SHUTS OFF. THIS WAS FOUND DURING PATIENT USE, WITH NO PATIENT INJURY REPORTED OR MEDICAL INTERVENTION NEEDED. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1