BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 19752132 · Received July 16, 2024

    Report

    Report Number
    2916596-2024-04470
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: FUNCTIONAL TESTING OF THE RETURNED OXYGENATOR BY THE MANUFACTURER (EUROSETS) WAS UNABLE TO CONFIRM THE REPORTED OXYGENATOR LEAK AND DETERMINED THAT THE DEVICE WAS COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE OXYGENATOR WAS RETURNED TO ABBOTT WHERE AN INITIAL VISUAL INSPECTION WAS PERFORMED THAT REVEALED NO OBVIOUS DAMAGE. THE OXYGENATOR WAS FORWARDED TO THE EXTERNAL MANUFACTURER (EUROSETS) FOR TECHNICAL ANALYSIS. THE OXYGENATOR WAS PLACED ON A MOCK LOOP WITH PHYSIOLOGICAL WATER. THE OXYGENATOR WAS FILLED USING A PERISTALTIC PUMP AT 6 LITERS PER MINUTE (LPM) AND REMAINED IN THE MOCK LOOP FOR 6 HOURS. DURING THIS TIME, THERE WERE NO OXYGENATOR LEAKS. THE DEVICE HISTORY RECORD FOR THE OXYGENATOR, LOT #7312508, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. DEVICES ARE REQUIRED TO PASS MANUFACTURING INSPECTIONS AND SPECIFICATIONS PRIOR TO RELEASE, AND NO ABNORMALITIES WERE DOCUMENTED WHICH WOULD CAUSE OR CONTRIBUTE TO THE REPORTED OCCURRENCE. THIS DEVICE PASSED ALL REQUIRED TESTING. BASED ON THEIR INTERNAL INVESTIGATION, EUROSETS CONFIRMED THAT THE OXYGENATOR WAS COMPLIANT WITH THE TECHNICAL SPECIFICATION, AND NO ISSUES WERE ABLE TO BE IDENTIFIED. EUROSETS COMMUNICATED THAT THIS EVENT WILL BE MONITORED WITHIN THE EUROSETS TREND REPORTING, AND IN THE CASE OF ADVERSE TRENDS, FURTHER INVESTIGATION AND/OR CORRECTIVE ACTIONS WILL BE CARRIED OUT. ALTHOUGH LEAKING WAS UNABLE TO BE CONFIRMED THROUGH THIS EVALUATION, ADDITIONAL INVESTIGATION OF OXYGENATOR LEAKING ISSUES HAS BEEN INITIATED BY ABBOTT AND SENT TO EUROSETS (OXYGENATOR SUPPLIER/MANUFACTURER) THROUGH A SUPPLIER CORRECTIVE ACTION REQUEST. THE PRODUCTION DOCUMENTATION FOR THE EUROSETS AMG PMP OXYGENATOR, LOT #7312508, 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), REV. 05, 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. IF YOU NOTICE LEAKAGE DURING PRIMING OR OPERATION, REPLACE THE DEFECTIVE DEVICE FOLLOWING GOOD PERFUSION PRACTICES. 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.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER NEEDED TO EMERGENTLY PLACE A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND DURING PRIMING OF THE OXYGENATOR, PRIMING SOLUTION STARTED POURING OUT OF THE YELLOW GAS EXHAUST PORT. AS SOON AS THE PRIMING FLUID HIT THE GAS EXHAUST PORT, IT STATED POURING OUT IMMEDIATELY. THERE WERE NO MEASUREMENT PRESSURES AT THAT POINT. THE PUMP SPEED DURING PRIMING WAS NOT PROVIDED. THE OXYGENATOR WAS REMOVED FROM THEIR CIRCUIT AND REPLACED WITH A NEW OXYGENATOR WHICH PRIMED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723146 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 7312508 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown