BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX F250NRE DIALYZER

    MDR report key: 3994433 · Received July 23, 2014

    Report

    Report Number
    1713747-2014-00365
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 24, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K082414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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 REPORTED THAT DURING TREATMENT, A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATE BLOOD LOSS WAS 300 CC'S. PATIENT HAD NO ADVERSE EFFECTS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. SAMPLE IS NOT AVAILABLE: SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432333 OPTIFLUX F250NRE DIALYZER KDI OGDEN MANUFACTURING 14DU02002

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR FRESENIUS 2008T MACHINE