BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 2960493 · Received January 25, 2013

    Report

    Report Number
    1713747-2013-00021
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 30, 2012
    Report Date
    December 30, 2012
    Manufacturer
    OGDEN MFG
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 AT THE INITIATION OF TREATMENT. ESTIMATED BLOOD LOSS WAS 150CC'S. PT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35961 OPTIFLUX 160NRE DIALYZER FINISHED ASSY HEMODIALYSIS DIALYZER FJI OGDEN MFG 12PU05007

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR FRESENIUS T MACHINE