BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 3802232 · Received March 24, 2014

    Report

    Report Number
    1713747-2014-00137
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 25, 2014
    Report Date
    February 25, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 NOT VISUALLY OBSERVED IN THE DIALYSATE. TEST STRIPS WERE USED TO CONFIRM AND THE MACHINE ALARMED. STRIP TESTED POSITIVE FROM THE RED HANSON DIALYZER. ESTIMATED BLOOD LOSS WAS LESS THAN 300 ML. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT COMPLETED TREATMENT ON A DIFFERENT MACHINE. SAMPLE HAS NOT BEEN RETURNED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171330 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13SU01015

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR 2008K2 HEMOLDIALYSIS MACHINE