BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 2922176 · Received January 16, 2013

    Report

    Report Number
    1713747-2013-00017
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    OGDEN MFG
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 250CC'S. PT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23439 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MFG 12PU05003

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR FRESENIUS 2008K MACHINE