BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3963381 · Received June 19, 2014

    Report

    Report Number
    1713747-2014-00299
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 22, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 FLUID LEAK OCCURRED. THE LEAK WAS VISUALLY OBSERVED. THE DIALYZER WAS FOUND TO BE CRACKED AND LEAKING DIALYSATE ONTO THE FLOOR. PATIENT'S BLOOD IN THE LINES WAS RETURNED TO PATIENT THEREFORE THERE WAS NO BLOOD LOSS. PATIENT COMPLETED TREATMENT ON A NEW SET UP. SAMPLE NOT AVAILABLE. ADDITIONAL ATTEMPTS TO THE CUSTOMER HAVE BEEN MADE WITH NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359411 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 14CU03004

    Patients

    Seq Age Sex Outcome Treatment
    1