BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAXPRISMAX SYSTEM

    MDR report key: 10704054 · Received October 20, 2020

    Report

    Report Number
    10704054
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CRRT MACHINE WITH ERRONEOUS ERROR MESSAGES. MAIN ALARM WAS INABILITY TO CALIBRATE PBP SCALE. LATER WHEN ATTEMPTING TO RESTART/CLEAR MACHINE MESSAGE THAT HAD NO RELATION TO WHAT WAS GOING ON WITH MACHINE, I.E.: "CASSETTE ERROR" WHEN THERE WAS NO CASSETTE IN PLACE (M100 HAD BEEN REMOVED AND TAKEN DOWN). MULTIPLE ATTEMPTS TO CLEAR SCALE BY OPENING AND CLOSING DOOR, TAKING PBP BAG OFF, TAKING HANDLE OFF, CHANGED PBP BAG FAILED PRIOR TO BEING FORCED TO RETURN BLOOD AND ATTEMPT WITH NEW M100. FAILED WITH NEW M100. MACHINE TURNED OFF BRIEFLY AND RESTARTED, AGAIN SCALES FAILED. MACHINE STOPPED AND POWERED DOWN. MANUFACTURER RESPONSE FOR CRRT, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169360 PRISMAXPRISMAX SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION 955626 CE063470

    Patients

    Seq Age Sex Outcome Treatment
    1 23360 DA