BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 2032232 · Received March 6, 2011

    Report

    Report Number
    2032232
    Event Type
    Malfunction
    Date Received
    March 6, 2011
    Date of Event
    January 28, 2011
    Report Date
    March 6, 2011
    Manufacturer
    GAMBRO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ON CONTINUOUS VENO VENOUS HEMODIAFILTRATION (CVVHDF) CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). IN THE MORNING, THE PRISMAFLEX MACHINE ALARMED DIALYSATE BAG EMPTY. THE MUTE BUTTON WAS PUSHED, THE SCALE OPENED AND THE DIALYSATE BAG CHANGED AND THE SCALE WAS CLOSED. IT WAS NOTED THAT THE REPLACEMENT BAG WAS NEAR EMPTY. THE REPLACEMENT SCALE WAS OPENED AND THE REPLACEMENT BAG WAS CHANGED. ONCE THE REPLACEMENT SCALE WAS CLOSED, THE CONTINUE BUTTON WAS PUSHED TO RESUME THERAPY. THE MACHINE ALARMED SCALE MALFUNCTION. THE MUTE AND RETEST BUTTONS WERE PUSHED. THE MACHINE AND BLOOD PUMP WOULD NOT RESUME THERAPY. THE PRACTITIONER WAS UNABLE TO GIVE BLOOD BACK AND THE CASSETTE WAS UNLOADED. THE STAFF ATTEMPTED TO PRIME A NEW CIRCUIT BUT THE ALARMS CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX CRRT KDI GAMBRO PRISMAFLEX *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR DIALYSIS