BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX F18NRE DIALYZER FINISHED ASSY

    MDR report key: 3031069 · Received March 28, 2013

    Report

    Report Number
    1713747-2013-00076
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    OGDEN MFG
    Product Code
    FJI
    PMA / PMN Number
    K043244
    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 INTERNAL LEAK WAS ON THE ARTERIAL END OF THE DIALYZER. ESTIMATED BLOOD LOSS WAS 5ML'S. PT HAD NO ILL EFFECTS. SAMPLE WAS DISCARDED BY THE USER FACILITY; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129074 OPTIFLUX F18NRE DIALYZER FINISHED ASSY HEMODIALYSIS DIALYZER FJI OGDEN MFG 10DU01011

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR