BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRD DIALYZER FINISHED ASSY

    MDR report key: 3802235 · Received March 24, 2014

    Report

    Report Number
    1713747-2014-00133
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    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

    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. AS BLOOD FILLED THE LINES THROUGH THE ARTERIAL CIRCUIT AND INTO THE ARTERIAL END OF THE DIALYZER, BLOOD ESCAPED THE DIALYZER AND FLOWED FREELY DOWN THE ARTERIAL HANSON LINES. TREATMENT WAS STOPPED IMMEDIATELY. TEST STRIPS WERE NOT USED TO CONFIRM AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 100 ML. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT COMPLETED TREATMENT ON A DIFFERENT SETUP AND MACHINE. SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171331 OPTIFLUX 160NRD DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 14AU06006

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR