BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3952960 · Received May 20, 2014

    Report

    Report Number
    1713747-2014-00249
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    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 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. THE LEAK WAS VISUALLY OBSERVED IN THE DIALYSATE. ESTIMATED BLOOD LOSS WAS LESS THAN 100CC'S. PT HAD NO ADVERSE EFFECTS. SAMPLE IS NOT AVAILABLE; SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299378 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI OGDEN MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR FRESENIUS 2008K MACHINE