BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 6122957 · Received November 22, 2016

    Report

    Report Number
    1713747-2016-00557
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 22, 2016
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A GROSS VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A SHORT FIBER AT APPROXIMATELY 10 DEGREES ON THE NON-CAVITY ID END OF THE DIALYZER AT APPROXIMATELY 10 DEGREES (WITH THE DIALYSATE PORTS AT 0 DEGREES). THE DIALYZER WAS THEN SUBJECTED TO A LABORATORY BUBBLE POINT LEAK TEST IN WHICH THE DIALYZER WAS PRESSURIZED AND SUBMERGED IN WATER; A LEAK WAS OBSERVED AS A STEADY STREAM OF BUBBLES ORIGINATING FROM THE POTTING CUT SURFACE ON THE NON-CAVITY ID END (AT THE LOCATION OF THE SHORT FIBER). THE DIALYZER WAS THEN SUBJECTED TO DESTRUCTIVE DISASSEMBLY TO BETTER ISOLATE THE LOCATION OF THE LEAK. THE FIBER BUNDLE WAS REMOVED FROM THE DIALYZER HOUSING AND SUBMERGED IN A WATER BATH WHILE COMPRESSED AIR PRESSURE WAS ALLOWED THROUGH THE FIBER BUNDLE AT A REGULATED RATE. AIR BUBBLES WERE DETECTED ESCAPING FROM THE SHORT FIBER FRAGMENT. NO OTHER DIALYZER DAMAGE OR IRREGULARITIES WERE IDENTIFIED. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE LOT PASSED ALL RELEASE CRITERIA. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE FAILURE MODE. A VISUAL EXAMINATION OF THE RETURNED DIALYZER OBSERVED A SHORT FIBER AT THE NON-CAVITY ID END. ADDITIONALLY, THE DIALYZER WAS SUBJECTED TO A LABORATORY LEAK TEST, WHICH CONFIRMED THE PRESENCE OF AN INTERNAL LEAK. THEREFORE, THE COMPLAINT HAS BEEN DEEMED CONFIRMED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A BLOOD LEAK OCCURRED IMMEDIATELY AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL DIALYZER LEAK. THE MACHINE ALARMED AND BLOOD WAS VISUALLY OBSERVED LEAKING IN THE DIALYSATE COMPARTMENT OF THE DIALYZER. BLOOD TEST STRIPS WERE USED AND POSITIVELY CONFIRMED THE PRESENCE OF BLOOD. NO DIALYZER DAMAGE WAS VISIBLE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 150 CC. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE IS AVAILABLE FOR EVALUATION BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773140 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, CAPILLARY, HOLLOW FIBER FJI OGDEN MANUFACTURING PLANT 16JU06008

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR FRESENIUS 2008K HEMODIALYSIS MACHINE| FRESENIUS BLOODLINE