BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 2872018 · Received December 11, 2012

    Report

    Report Number
    1713747-2012-00232
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    OGDEN MFG
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    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 LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED WITH A BLOOD LEAK ALARM. ESTIMATED BLOOD LOSS WAS 20-50 CC¿S. THERE WAS NO ILL EFFECT TO THE PT. THERE IS A SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MFG 12KU02012

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR FRESENIUS K2 MACHINE