BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORY DRAIN BAG

    MDR report key: 1904397 · Received November 14, 2010

    Report

    Report Number
    1904397
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    October 9, 2010
    Report Date
    November 14, 2010
    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 PRACTITIONER WALKED INTO THE PT'S ROOM TO CHECK AND LOOK OVER THE DIALYSIS MACHINE, A CONTINUOUS RENAL REPLACEMENT (CRRT PRISMAFLEX). I NOTICED THAT THE EFFLUENT DRAIN BAG HANGING ON THE SCALE WAS LEAKING FLUID ONTO THE FLOOR FROM WHAT APPEARED TO BE A FAULTY VALVE ON THE BOTTOM OF THE BAG. I THEN COMPLETED A BAG CHANGE ON THE PRISMAFLEX AND PLACED A NEW DRAIN BAG ON THE SCALE AND DRAINED THE LEAKY BAG. ONCE THE BAG CHANGE WAS COMPLETE, I PROCEEDED TO CLEAN UP THE WET FLOOR. THE BAG WAS SAVED FOR BIOMED. IT WAS EFFLUENT BAG/LOT NUMBER: 0002171.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESSORY DRAIN BAG ACCESSORY DRAIN BAG KDI GAMBRO * LOT UNKNOWN; LOT0002171 ON BAG

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR DIALYSIS