BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX F250NRE DIALYZER

    MDR report key: 3894757 · Received May 19, 2014

    Report

    Report Number
    1713747-2014-00246
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K082414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY HAS REPORTED DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS NOT VISUALLY OBSERVED, BUT THE TEST STRIPS TESTED POSITIVE, AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 300CC'S. PT REQUIRED NO MEDICAL INTERVENTION. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296174 OPTIFLUX F250NRE DIALYZER KDI OGDEN MANUFACTURING 14BU02007

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR FRESENIUS 2008K2 MACHINE