BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 17585986 · Received August 21, 2023

    Report

    Report Number
    3003752502-2023-02395
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    August 1, 2023
    Report Date
    December 7, 2023
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1A-6: PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME. A REQUEST FOR FURTHER INFORMATION WILL BE SENT. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    A1-A6: THERE WAS NO PATIENT INVOLVEMENT, THEREFORE NOT APPLICABLE. MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED PHOTOS CONFIRMED THE REPORTED OXYGENATOR LEAK; HOWEVER, A SPECIFIC ROOT CAUSE FOR THIS FINDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION AS THE OXYGENATOR WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT A NEWLY PRIMED CIRCUIT WAS FOUND TO HAVE A LEAK FROM THE OXYGENATOR WITH FLUID COMING OUT OF THE BOTTOM. THE DEVICE WAS TAKEN OUT OF CIRCULATION FOR PATIENT USE. THE SUBMITTED PHOTOS WERE REVIEWED AND SHOWED THAT THE CIRCUIT/OXYGENATOR APPEARED TO BE PRIMED WITH CLEAR FLUID. A DROP OF CLEAR FLUID WAS NOTED NEAR THE INLET ON THE BOTTOM BLUE SECTION. THE EUROSETS AMG PMP OXYGENATOR, LOT # 7896808, WAS NOT RETURNED FOR EVALUATION. THE PRODUCTION DOCUMENTATION FOR THE OXYGENATOR WERE REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. EUROSETS CONFIRMED THAT OXYGENATORS UNDERGO MULTIPLE LEAKAGE TESTS DURING PRODUCTION, AND DEVICES THAT EXHIBIT LEAKS ARE DISCARDED PRIOR TO DISTRIBUTION. DEVICES ARE REQUIRED TO PASS MANUFACTURING INSPECTIONS AND SPECIFICATIONS PRIOR TO RELEASE, AND NO ABNORMALITIES WERE DOCUMENTED IN THE DEVICE HISTORY RECORD WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED OCCURRENCE. THE DEVICE PASSED ALL REQUIRED TESTING. BASED ONLY ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED BY EUROSETS. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) WARNS THAT DURING EXTRACORPOREAL CIRCULATION (ECC) A BACKUP OXYGENATOR IS NECESSARY AND WARNS THAT THE DEVICE MUST BE CAREFULLY AND CONTINUOUSLY CHECKED BY QUALIFIED HEALTHCARE PROFESSIONALS. BEFORE USING THE PRODUCT, IT IS ADVISABLE TO FULLY INSPECT IT AS TRANSPORT AND/OR STORAGE CONDITIONS OTHER THAN THOSE PRESCRIBED MAY HAVE CAUSED DAMAGE TO THE DEVICE. THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, LOT NUMBER 7896808, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS MADE IN THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING USE, A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE AND ALSO WARNS THAT THE DEVICE HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED BY QUALIFIED HEALTHCARE PROFESSIONALS THROUGHOUT THE PROCEDURE. ALSO, UNDER THE SECTION TITLED ¿SET UP¿, THE IFU WARNS TO ¿CARRY OUT A VISUAL INSPECTION AND CAREFULLY CHECK THE DEVICE BEFORE USE. TRANSPORT AND/OR STORAGE CONDITIONS OTHER THAN THOSE PRESCRIBED MAY HAVE CAUSED DAMAGE TO THE DEVICE.¿ UNDER THE SECTION TITLED ¿OXYGENATOR REPLACEMENT¿, THIS DOCUMENT STATES THAT A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE DURING PERFUSION. AFTER 6 HOURS OF USE WITH BLOOD OR IF PARTICULAR SITUATIONS OCCUR, WHICH MAY LEAD THE PERSON RESPONSIBLE FOR PERFUSION TO DETERMINE THE SAFETY OF THE PATIENT MAY BE COMPROMISED (INSUFFICIENT OXYGENATOR PERFORMANCE, LEAKS, ABNORMAL BLOOD PARAMETERS, ETC.), FOLLOW THE PROCEDURE OUTLINED IN THE IFU FOR OXYGENATOR REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEWLY PRIMED OXYGENATOR HAD FLUID LEAKING FROM THE BOTTOM. THE OXYGENATOR WAS REMOVED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905613 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 7896808 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown