BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY

    MDR report key: 3802251 · Received March 24, 2014

    Report

    Report Number
    1713747-2014-00132
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 1, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DIALYZER HEADER WAS NOT SEALED. TEST STRIPS WERE USED TO CONFIRM AND THE MACHINE DID NOT ALARM. ESTIMATED BLOOD LOSS WAS 250 CC. PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. PATIENT WAS ABLE TO COMPLETE TREATMENT ON A NEW SYSTEM. SAMPLE HAS NOT BEEN RETURNED TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171332 OPTIFLUX 180NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 14A505009

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 2008T HEMODIALYSIS MACHINE