BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3822749 · Received February 7, 2014

    Report

    Report Number
    1713747-2014-00057
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 HAS REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 100CC'S. PT HAD NO ADVERSE EFFECTS AND DID NOT REPORT ANY MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE, SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80845 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 13PU05017

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR FRESENIUS 2008T MACHINE