BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3063285 · Received March 1, 2013

    Report

    Report Number
    1713747-2013-00053
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 4, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. UPON INITIATION OF TREATMENT, THERE WAS A BLOOD LEAK ALARM. THE LEAK WAS VISUALLY OBSERVED AND TEST STRIPS WERE USED TO CONFIRM THE BLOOD LEAK. ESTIMATED BLOOD LOSS WAS 200CC¿S. PATIENT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89889 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING 12KU05004

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR FRESENIUS 2008K MACHINE