BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 2904666 · Received January 4, 2013

    Report

    Report Number
    1713747-2013-00006
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 8, 2012
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 BLOOD LEAK WAS VISUALLY OBSERVED AT THE INITIATION OF TREATMENT. BLOOD WAS VISUALLY OBSERVED IN THE DIALYSATE OUTFLOW LINE. A VISUAL INSPECTION OF THE DIALYZER BY THE FACILITY FOUND NO DEFECTS ON THE DEVICE. THERE WAS NO PT ILL EFFECTS. SAMPLE WAS DISCARDED BY THE USER FACILITY; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5079 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING 12HU05009

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR