BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    MDR report key: 4840441 · Received June 11, 2015

    Report

    Report Number
    1713747-2015-00272
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATOR SUBJECTED THE DIALYZER TO A LABORATORY BUBBLE POINT TEST WHERE TESTING WAS INCONCLUSIVE DUE TO THE COAGULATED BLOOD FOUND AT BOTH CAVITY ID END AND NON-CAVITY ID END BLOOD COMPARTMENTS HOWEVER, THE COMPLAINT INVESTIGATOR WAS ABLE TO VISUALLY CONFIRM THE PRESENCE OF BLOOD WITHIN THE DIALYSATE CHAMBER AT THE CAVITY ID END BELL HOUSING AS SUCH, THIS COMPLAINT IS CONFIRMED AS A BLOOD LEAK. THE DIALYZER WAS SUBJECTED TO A DESTRUCTIVE DISASSEMBLY OF THE DIALYZER TO BETTER VISUALLY EXAMINE THE DIALYZER. BOTH SONIC WELDER SCREW FLANGES WERE REMOVED TO INSPECT THE POLYURETHANE POTTING. VISUAL EXAMINATION OF THE POLYURETHANE POTTING NOTED THAT BOTH POLYURETHANE POTTING ENDS REMAINED INTACT. THERE WERE NO VISUAL SEPARATIONS ON THE POTTING CUT SURFACE AND THERE WERE NO DISPLACED OR STAY FIBERS AWAY FROM THE FIBER BUNDLE. THE FIBER BUNDLE WAS THEN REMOVED FROM THE DIALYZER HOUSING WHERE NO BROKEN, LOOSE, LOOPED/KINKED, OR SHORT FIBERS WERE OBSERVED. THE INFERIOR SURFACES OF THE POLYURETHANE POTTING WERE EXAMINED BY REMOVING THE FIBER MEMBRANE. THERE WERE NO VOIDS OBSERVED AND BOTH POTTING MASSES WERE WITHIN ACCEPTABLE PARAMETERS. NOTE. THE BUBBLE POINT TEST COULD NOT BE RE-PERFORMED AFTER SCRAPPING THE COAGULATED BLOOD OFF FROM THE POTTING CUT SURFACES. DAMAGES CAN BE CAUSED TO EITHER THE THREADS TO THE SCREW FLANGES AND/OR THE DIALYZER HOUSING OR THE SCREW FLANGES CAN CRACK WHEN REMOVING THE SONICALLY WELDED SCREW FLANGES. ONCE DIALYZER PRODUCT IS EXPOSED TO A POST-PRODUCTION ENVIRONMENT, SUCH COMBINATION AS CLINIC USE, IT IS NO LONGER OF AN ORIGINAL STATE AS SEEN IN QUALITY TESTING FOR THE RELEASE OF PRODUCT, AS A RESULT, LABORATORY TESTING MAY BE INCONCLUSIVE REGARDING THE FAILURE ORIGINALLY OBSERVED BY THE COMPLAINANT FACILITY.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FIELD UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEK OCCURRED. THE LEAK WAS REPORTED TO BE AN INTERNAL DIALYZER LEAK. THE MACHINE ALARMED. TEST STRIPS WERE USED TO CONFIRM THE LEAK. ESTIMATED BLOOD LOSS WAS 90ML. THE PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT. SAMPLE IS AVAILABLE FOR MANUFACTURING EVALUATION AND HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381529 OPTIFLUX 160NRE DIALYZER FINISHED ASSY FJI FRESENIUS MEDICAL CARE NORTH AMERICA 15BU01009

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR