BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY

    MDR report key: 3964006 · Received May 8, 2014

    Report

    Report Number
    1713747-2014-00230
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. TEST STRIPS WERE USED TO CONFIRM AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 300 CC'S. PT HAD NO ADVERSE EFFECTS ADN NO MEDICAL INTERVENTION WAS REQUIRED. SAMPLE WAS DISPOSED OF THEREFORE NOT AVAILABLE FOR MFR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279568 OPTIFLUX 180NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 14BU02016

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR FRESENIUS 2008K HEMODIALYSIS MACHINE