BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG, ACCESSORY DRAIN

    MDR report key: 1872743 · Received September 26, 2010

    Report

    Report Number
    1872743
    Event Type
    Malfunction
    Date Received
    September 26, 2010
    Date of Event
    July 16, 2010
    Report Date
    September 26, 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

    A CRRT 5 LITER BAG WAS FOUND TO BE LEAKING. THE LOT NUMBER ENGRAVED ON THE BAG WAS FOUND TO BE DIFFERENT THAN THE LOT NUMBER ON THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAG, ACCESSORY DRAIN ACCESSORY DRAIN BAG KDI GAMBRO NA BAG LOT # 0000171;PACKAGE 1013

    Patients

    Seq Age Sex Outcome Treatment
    1 * DIALYSIS