BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 200NRE DIALYZER FINISHED ASSY.

    MDR report key: 4001303 · Received July 21, 2014

    Report

    Report Number
    1713747-2014-00359
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 REPORTED ONE MINUTE INTO TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED LEAKING OUT OF DIALYZER UNDER THE RIM OF ATRIAL END. TEST STRIPS WERE USED TO CONFIRM. THE MACHINE DID NOT ALARMED. ESTIMATED BLOOD LOSS WAS 150 ML. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424013 OPTIFLUX 200NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13PU04001

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR FRESENIUS 2008K2 HEMODIALYSIS MACHINE