BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3190469 · Received June 21, 2013

    Report

    Report Number
    1713747-2013-00225
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, HOWEVER, A COMPANION SAMPLE FROM THE SAME LOT WAS RETURNED FOR INVESTIGATION AND NO DEFECTS WERE NOTED. IN ADDITION, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A BLOOD LEAK ONCE DIALYSIS COMMENCED. THEY REPORT THAT IT WAS ON OBVIOUS BLOOD LEAK AND THEY WERE UNABLE TO RETRANSFUSE BLOOD. THE DOCTOR WAS NOTIFIED AND CBC ORDERED POST DIALYSIS. THE PATIENT'S APPROXIMATE BLOOD LOSS WAS 200-300 CC'S. THE PATIENT IS DOING WELL AND NOT REQUIRE ANY INTERVENTION AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283721 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13AU01012

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR