BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 9734040 · Received February 20, 2020

    Report

    Report Number
    1713747-2020-00048
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    February 5, 2020
    Report Date
    April 13, 2020
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    KDI
    UDI-DI
    00840861100156
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, H3 PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CORPORATE PROVIDED BLOOD PORT CAPS AND ADAPTER CAPS WERE RETURNED ATTACHED TO THE DIALYZER. THE FIBERS WITHIN THE DEVICE WERE WET. THE RETURNED SAMPLE WAS SUBJECTED TO A LABORATORY LEAK TEST IN WHICH THE DIALYZER WAS SUBMERGED IN WATER AND PRESSURIZED INCREMENTALLY. AN EXTERNAL LEAK WAS OBSERVED IN THE FORM OF A STEADY STREAM OF BUBBLES ORIGINATING FROM THE NON-CAVITY ID END AT APPROXIMATELY 4.0 POUNDS PER SQUARE INCH (PSI). THE DIALYZER WAS SUBJECTED TO DESTRUCTIVE DISASSEMBLY FOR FURTHER VISUAL EXAMINATION. UPON REMOVAL OF THE HEADER CAP, A CHIP, MEASURING APPROXIMATELY 0.5 CM IN LENGTH, WAS OBSERVED ON THE POTTING SURFACE AT APPROXIMATELY 35 DEGREES WITH THE PORTS SITUATED AT 0 DEGREES. FURTHER VISUAL EXAMINATION DID NOT IDENTIFY ANY OTHER DAMAGE OR IRREGULARITIES ON THE RETURNED SAMPLE. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. THE REVIEW REVEALED THERE WERE TWO NON-CONFORMANCES (NCS): BUBBLES IN HOUSING, AND A HIGH PERCENTAGE OF DELAMINATIONS FOUND DURING INSPECTION. THE BUBBLES IN HOUSING NC WAS UNRELATED TO THE COMPLAINT EVENT. REWORK WAS PERFORMED DUE TO THE HIGH PERCENTAGE OF DELAMINATIONS FOUND, AND ALL DISCREPANT PRODUCT WAS DISCARDED. THE REMAINDER OF THE LOT MET RELEASE CRITERIA. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED BY THE MANUFACTURER. THERE WAS NO INDICATION OF PRODUCT NONACCEPTANCE, DEVIATION, NON-CONFORMANCE, REWORK, LABELING OR PROCESS CONTROL FAILURE DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE LOT MET ALL RELEASE CRITERIA. THE INVESTIGATION INTO THE COMPLAINT WAS ABLE TO CONFIRM THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A USER FACILITY CLINIC MANAGER (CM) REPORTED THAT AN EXTERNAL DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AT THE ONSET OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE LEAKING BEGAN AS SOON AS BLOOD REACHED THE DIALYZER. BLOOD WAS VISUALLY OBSERVED LEAKING FROM THE HEADER CAP, AND DOWN THE EXTERIOR OF THE DEVICE¿S BODY. THE MACHINE, A FRESENIUS 2008T, DID NOT ALARM. FRESENIUS BLOODLINES WERE USED FOR THE TREATMENT. BLOOD LEAK TEST STRIPS WERE NOT USED. THERE WAS NO REPORTED DAMAGE IDENTIFIED ON THE DIALYZER. AFTER IDENTIFYING THE BLOOD LEAK, TREATMENT WAS HALTED AND THE PATIENT¿S BLOOD WAS NOT RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 200 ML. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS ABLE TO COMPLETE TREATMENT AFTER BEING RE-SETUP WITH NEW SUPPLIES ON A DIFFERENT MACHINE. THE DIALYZER WAS REPORTEDLY AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196934 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OGDEN MANUFACTURING PLANT 0500318E 19PU07003 00840861100156

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR FRESENIUS 2008T MACHINE| FRESENIUS BLOODLINES