BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDALONE PMP NEONATAL OXYGENATOR

    MDR report key: 20788538 · Received November 26, 2024

    Report

    Report Number
    3003752502-2024-00036
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 6, 2024
    Report Date
    January 16, 2025
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K202510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 FIBER BREAKAGE; HOWEVER, A SPECIFIC ROOT CAUSE FOR THE FIBER BREAKAGE 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 10 MINUTES. A SLOW DRIP IN THE LOWER PART OF THE OXYGENATOR WAS CONFIRMED. THE DEVICE WAS SECTIONED BY REMOVING THE LOWER HOUSING, REFILLED WITH WATER, AND PRESSURIZED. THE POINT OF LOSS OCCURRED DUE TO THE FIBER BREAKAGE OF THE LAST WINDING OF FIBERS NEAR THE ARTERIAL OUTLET PORT. THE DEVICE HISTORY RECORD FOR THE INFANT OXYGENATOR, LOT #9230300, 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. 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 DETERMINED THAT THE ISSUE OCCURRED AFTER EUROSETS¿ MANUFACTURING AND TEST PHASES. 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 INFANT OXYGENATOR, LOT #9230300, 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 INFANT CARDIOPULMONARY BYPASS OXYGENATOR INSTRUCTIONS FOR USE (IFU), REV. 00, IS CURRENTLY AVAILABLE. THE IFU INCLUDES WARNINGS: -THAT THE DEVICE IS INTENDED TO BE USED BY PROFESSIONALLY TRAINED PERSONNEL. -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. -THAT DURING USE, A SPARE A.M.G. PMP INFANT OXYGENATOR MUST ALWAYS BE AVAILABLE. 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. THIS SECTION ALSO INSTRUCTS TO CHECK THAT ALL CONNECTIONS ARE PROPERLY SECURED. 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 COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OXYGENATOR FAILURE WHEN PRIMING AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT. ONCE THE CIRCUIT WAS PRIMED, A LEAK WAS NOTED FROM THE BOTTOM OF THE OXYGENATOR. UPON FURTHER INSPECTION, IT SEEMED TO BE DRIPPING FROM THE BOTTOM WHERE THE ORANGE AND BLUE PLASTIC / THE VENOUS INLET WERE LOCATED. IT WAS FELT THAT THE LEAK MIGHT BE COMING FROM THE HEAT EXCHANGER INTERNALLY OR AN INTERNAL RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850220 STANDALONE PMP NEONATAL OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5088 9230300 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown