BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 19707429 · Received July 9, 2024

    Report

    Report Number
    3003752502-2024-00021
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 14, 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
    PA, 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) CONFIRMED AN OXYGENATOR LEAK DUE TO A CRACK ON THE BLOOD INLET LUER CONNECTION; HOWEVER, A SPECIFIC ROOT CAUSE FOR THE DAMAGE 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 REMAINED IN THE MOCK LOOP FOR 10 MINUTES AT 1.5 ATMOSPHERES. A SLOW DRIP IN THE LOWER PART OF THE HEAT EXCHANGER WAS CONFIRMED, AT THE BLOOD INLET LUER CONNECTION. EUROSETS DETERMINED THAT THE IDENTIFIED CRACK ON THE BLOOD INLET LUER CONNECTION COULD BE DUE TO AN IMPACT DURING THE HANDLING OF THE DEVICE. THE DEVICE HISTORY RECORD FOR THE OXYGENATOR, LOT #9945208, WAS REVIEWED BY THE EXTERNAL MANUFACTURER 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. EUROSETS CONFIRMED THAT 100% OF THE OXYGENATORS PRODUCED ARE TESTED TO DETECT EVENTUAL LEAKAGES USING A PRESSURE OF 150 KPA (KILOPASCALS) WHICH IS 1.5 TIMES THE MAXIMUM BLOOD PATHWAY PRESSURE INDICATED ON THE IFU (INSTRUCTIONS FOR USE). DEVICES THAT EXHIBIT LEAKS ARE DISCARDED PRIOR TO DISTRIBUTION. EUROSETS COMMUNICATED THAT THEIR PRODUCTION PROCESS AND CONTROLS WILL CONTINUE TO BE IMPROVED TO FURTHER REDUCE THE OCCURRENCE RATE OF THESE EVENTS, WHICH WILL ALSO BE MONITORED FOR ADVERSE TRENDS. 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 #9945208 / SERIAL #09945208F0515, 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. THE IFU WARNS TO CAREFULLY CHECK THE DEVICE SEAL DURING PRIMING AND OPERATION. 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

    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 PRIMING SOLUTION WAS NOTED TO BE LEAKING AND COMING OUT FROM WHERE THE CLEAR AND ORANGE PLASTIC MEET AT THE BASE OF THE OXYGENATOR FIBERS. THIS WAS NOTED IMMEDIATELY DURING GRAVITY PRIMING OF THE OXYGENATOR. THERE WAS NO PATIENT INVOLVED AND NO MECHANICAL CIRCULATORY SUPPORT (MCS) WAS IN USE AND NO MEMBRANE PRESSURES WERE TRANSDUCED. THE OXYGENATOR WAS IMMEDIATELY REPLACED AND THE SUBSEQUENT OXYGENATOR FUNCTIONED AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254891 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 09945208 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown