BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 6082850 · Received November 7, 2016

    Report

    Report Number
    1713747-2016-00548
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 5, 2016
    Report Date
    December 1, 2016
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXAMINATION OF THE RETURNED DEVICE NOTED A POLYURETHANE (PU) DELAMINATION ON THE CAVITY ID END OF THE DIALYZER. THE DELAMINATION MEASURED APPROXIMATELY 315 DEGREES TO 45 DEGREES WITH THE DIALYSATE PORTS AT ZERO DEGREES. THE DELAMINATION MANIFESTED AS SEPARATIONS OF THE PU (POTTING MATERIAL) FROM THE DIALYZER HOUSING (WALL). THE COMPLAINT INVESTIGATOR OBSERVED THE POTTING CUT SURFACE OF THE PU ON THE CAVITY ID END WAS NOT EVENLY DISTRIBUTED; THE SURFACE WAS IRREGULAR AND CONCAVED. THE POTTING CUT HEIGHT OF THE PU WAS MEASURED USING A CALIBRATED CALIPER AND ALL THE MEASUREMENTS WERE WITHIN THE ACCEPTABLE PARAMETERS. THERE WERE NO DAMAGES OR IRREGULARITIES NOTED ON THE NON-CAVITY ID END. 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 COMPLAINT OF "INTERNAL BLOOD LEAK." IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE LOT MET ALL RELEASE CRITERIA. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE FAILURE MODE. DELAMINATION OF THE POLYURETHANE (PU) POTTING COMPOUND WAS OBSERVED ON THE CAVITY ID END OF THE DIALYZER. THE DELAMINATION WAS NOT EVENLY DISTRIBUTED COMPROMISING THE SEAL BETWEEN THE PU MATERIAL AND THE O-RINGS, WHICH MAY HAVE ALLOWED A LEAK PATHWAY INTO THE DIALYSATE COMPARTMENT. 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ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 20CC. 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 TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    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 20CC. 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 TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733051 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, CAPILLARY, HOLLOW FIBER FJI OGDEN MANUFACTURING PLANT 16EU01009

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR FRESENIUS 2008T HEMODIALYSIS MACHINE| FRESENIUS BLOODLINE