BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3905776 · Received May 29, 2014

    Report

    Report Number
    1713747-2014-00267
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. PATIENT WAS ALARMING AND PCT NOTICED A HAIRLINE BLOOD LEAK AT THE TOP OF THE DIALYZER. ESTIMATED BLOOD LOSS WAS 250 ML. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CHOSE TO NOT COMPLETE TREATMENT. SAMPLE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317425 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 14CU01012

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR FRESENIUS 2008K HEMODIALYSIS MACHINE