BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MACHINE, CRRT

    MDR report key: 2210130 · Received July 30, 2011

    Report

    Report Number
    2210130
    Event Type
    Malfunction
    Date Received
    July 30, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 30, 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 FILTER ALARMED FOR DIALYSATE WEIGHT. WE ASSURED TUBING WAS NOT INFLUENCING PRESSURES. CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) CONTINUED WITH NO PROBLEM. SAME ALARM APPROXIMATELY IN 45 MINUTES. DIALYSATE AND REPLACEMENT FLUID BAGS REPLACED. NEXT ALARM SHORTLY AFTER AND FILTER CLOTTED MESSAGE RIGHT AFTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR