BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX F250NRE DIALYZER

    MDR report key: 3042838 · Received April 4, 2013

    Report

    Report Number
    1713747-2013-00081
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K864587
    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 LEAK WAS INTERNAL AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS LESS THAN 100 CC'S. PATIENT HAD NO ILL EFFECTS. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138965 OPTIFLUX F250NRE DIALYZER HEMODIALYSIS DIALYZER KDI OGDEN MANUFACTURING 12SU02006

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS H MACHINE