BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3063318 · Received March 1, 2013

    Report

    Report Number
    1713747-2013-00054
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 4, 2013
    Manufacturer
    OGDEN MFG
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 WITH BLOOD IN THE DIALYSATE LINE. ESTIMATED BLOOD LOSS WAS UNK. PATIENT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90222 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MFG 13AU02002

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR FRESENIUS T MACHINE