BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F6 DIALYZER FINISHED ASSY (CASE)

    MDR report key: 6067928 · Received October 31, 2016

    Report

    Report Number
    1713747-2016-00547
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 5, 2016
    Report Date
    November 22, 2016
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    FJI
    PMA / PMN Number
    K870725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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 FIBER ON THE CIRCUMFERENCE OF THE FIBER BUNDLE ON THE CAVITY ID END OF THE DIALYZER AT APPROXIMATELY 110 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 CAVITY ID END (AT THE LOCATION OF THE OBSERVED FIBER). ONE END OF THE FIBER WAS POTTED ON THE CAVITY ID END AND THE OTHER END WAS NOT POTTED. THE FIBER MEASURED APPROXIMATELY 16.5CM FROM THE INFERIOR SIDE OF THE CAVITY ID END PASSING THE KNIT LINE, AND ENDED BETWEEN THE KNIT LINE AND BELL HOUSING OF THE NON-CAVITY ID END. THE END OF THE FIBER THAT WAS NOT POTTED WAS FOUND TO BE PINCHED. NO ADDITIONAL FIBER FRAGMENTS AND NO BROKEN PIECES WERE NOTED WITHIN THE DIALYZER. 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 AN IRREGULAR FIBER AT THE CAVITY ID END. ADDITIONALLY, THE DIALYZER WAS SUBJECTED TO A LABORATORY LEAK TEST, WHICH CONFIRMED THE PRESENCE OF AN INTERNAL LEAK AT THE LOCATION OF THE OBSERVED FIBER. THEREFORE, THE COMPLAINT HAS BEEN DEEMED CONFIRMED.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON THE COMPLETION OF THIS ACTIVITY.

    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. THEREFORE, BLOOD TEST STRIPS WERE NOT USED TO CONFIRM THE PRESENCE OF BLOOD. NO DIALYZER DAMAGE WAS VISIBLE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS REPORTED AS BEING APPROXIMATELY 150CC. 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.

    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. THEREFORE, BLOOD TEST STRIPS WERE NOT USED TO CONFIRM THE PRESENCE OF BLOOD. NO DIALYZER DAMAGE WAS VISIBLE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS REPORTED AS BEING APPROXIMATELY 150CC. 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
    718966 F6 DIALYZER FINISHED ASSY (CASE) DIALYZER, CAPILLARY, HOLLOW FIBER FJI OGDEN MANUFACTURING PLANT 15HU01007

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR