BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3963999 · Received May 8, 2014

    Report

    Report Number
    1713747-2014-00232
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE MACHINE ALARMED. TREATMENT WAS STOPPED. PT WAS SET UP ON NEW MACHINE BUT WAS NOT ABLE TO COMPLETE TREATMENT DUE TO WATER SUPPLY PROBLEM AT FACILITY. PT RETURNED FOR REGULARLY SCHEDULED TREATMENT AND RECEIVED AN EXTRA HALF HOUR TREATMENT. ESTIMATED BLOOD LOSS WAS 250 ML. PT'S HEMO WAS LOW. EPOGEN INCREASED. PT HAD NO OTHER ADVERSE EFFECTS. SAMPLE HAS BEEN DISCARDED THEREFORE MFR WAS UNABLE TO EVALUATE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277261 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 14AU06015

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 2008K HEMODIALYSIS MACHINE