BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX F250NRE DIALYZER

    MDR report key: 3894760 · Received May 19, 2014

    Report

    Report Number
    1713747-2014-00244
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 22, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K082414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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 REPORTED DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED, TEST STRIPS WERE USED AND THEY TESTED POSITIVE, AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 200CC'S. TREATMENT WAS DISCONTINUED AND PT WAS SET UP ON A NEW MACHINE. PT HAD NO ADVERSE EFFECTS AND REQUIRED NO MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE, SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296093 OPTIFLUX F250NRE DIALYZER KDI OGDEN MANUFACTURING 13SU02015

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR FRESENIUS 5008 MACHINE