BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 6105972 · Received November 16, 2016

    Report

    Report Number
    1713747-2016-00554
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 21, 2016
    Report Date
    December 12, 2016
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 DELAMINATION IN THE PU POTTING EXTENDED UNDER THE SILICONE O-RING. THE DIALYZER WAS THEN SUBJECTED TO DESTRUCTIVE DISASSEMBLY FOR FURTHER VISUAL ANALYSIS. FURTHER EXAMINATION OF THE FIBER BUNDLE DID NOT REVEAL ANY DAMAGE OR IRREGULARITIES WITHIN THE FIBER BUNDLE; SPECIFICALLY, NO BROKEN, LOOSE FIBER FRAGMENTS, AND/OR KINKED, LOOPED, OR SHORT FIBERS. THE INFERIOR SURFACE OF BOTH POLYURETHANE POTTING ENDS WERE EXAMINED FOR VOIDS. NO VOIDS WERE PRESENT. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WAS ONE DEVIATION NOTICE NOTED ON THE LOT; HOWEVER, THERE WAS NO INDICATION OF PRODUCT NON-ACCEPTANCE OR DEVIATION DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED COMPLAINT OF "INTERNAL BLOOD LEAK." THIS INCLUDES NON-CONFORMANCES, REWORK, LABELING, PROCESS CONTROLS, AND ANY OTHER OCCURRENCE IN PRODUCTION POTENTIALLY RELATED TO THE COMPLAINT. 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 IN THE POTTING EXTENDED UNDERNEATH THE SILICONE O-RING AND COMPROMISED THE SEAL BETWEEN THE PU MATERIAL AND THE O-RING, 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. 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 NOTED AS BEING APPROXIMATELY 100CC. 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 WAS 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. 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 NOTED AS BEING APPROXIMATELY 100CC. 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 WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757829 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, CAPILLARY, HOLLOW FIBER FJI OGDEN MANUFACTURING PLANT 16KU05011

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR FRESENIUS 2008T HEMODIALYSIS MACHINE| FRESENIUS BLOODLINE