BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3140054 · Received May 29, 2013

    Report

    Report Number
    1713747-2013-00157
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCE 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 FOLLOWING WAS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING TREATMENT THE DIALYSIS MACHINE ALARMED AND BLOOD WAS OBSERVED IN THE LINES. THE BLOOD FLOW RATE WAS 200, DIALYSATE FLOW RATE 500. BLOOD TEST STRIPS WERE NOT USED. ESTIMATED BLOOD LOSS WAS LESS THAN 100 CC. PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233911 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI 13CU04014

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR MACHINE TYPE T