BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 1081147 · Received July 11, 2008

    Report

    Report Number
    1081147
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 11, 2008
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRISMA SET WAS CONNECTED TO PATIENT RECEIVING CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) AND THE TUBING SNAPPED OFF FROM THE ADAPTERS INTO THE EVA MIXING CONTAINER. DIALYSIS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA TUBING, DIALYSIS, CRRT FJK GAMBRO RENAL PRODUCTS, INC. 8399050 4571250

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR NO OTHER THERAPIES| NO OTHER THERAPIES