BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER SYRINGE PUMP

    MDR report key: 1003145 · Received February 4, 2008

    Report

    Report Number
    6000001-2008-00029
    Event Type
    Injury
    Date Received
    February 4, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 22, 2008
    Manufacturer
    *
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH MULTIPLE CALLS HAVE BEEN PLACED TO THE FACILITY REQUESTING ADDITIONAL CLINICAL INFO, NO RESPONSE HAS BEEN REC'D. SHOULD THE PUMP BE REC'D FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUAITON OR IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A VOLUNTARY MEDWATCH WAS REC'D FROM THE FACILITY INDICATING: THE MEDICATION PROGRAMMING SCREEN FROZE; UNABLE TO RESTART DRIPS AFTER VOLUME LIMIT WAS REACHED. THE PUMPS WERE EXCHANGED AND DRIPS WERE RESTARTED ON A NEW PUMP. THE MEDICATION PAUSE AFFECTED THE PT'S BLOOD PRESSURE, NECESSITATING ADMINISTRATION OF FLUID BOLUSES (UNKNOWN) AND INCREASED DRIP RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER SYRINGE PUMP * FRN * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *