BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3042839 · Received April 4, 2013

    Report

    Report Number
    1713747-2013-00080
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE INTERNAL LEAK WAS VISUALLY OBSERVED FROM BROKEN FIBERS SEEN NEAR THE HEADER OF THE DIALYZER AND THE MACHINE ALARMED. TEST STRIPS WERE USED TO CONFIRM THE BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 200 CC'S. PATIENT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138084 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER KDI OGDEN MANUFACTURING 13AU06025

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR FRESENIUS T MACHINE