BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDALONE PMP NEONATAL OXYGENATOR

    MDR report key: 19893678 · Received August 2, 2024

    Report

    Report Number
    3003752502-2024-00024
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 15, 2024
    Report Date
    January 30, 2025
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    QNR
    UDI-DI
    08052705496253
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED OXYGENATOR BY THE MANUFACTURER (EUROSETS) CONFIRMED BLOOD LEAKAGE 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. BLOOD WAS FOUND IN THE OXYGENATOR¿S BOTTOM HOUSING, WITHIN THE GAS PATHWAY, WHICH PROVIDED EVIDENCE OF THE REPORTED BLOOD LEAK. 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, THE OXYGENATOR DID NOT LEAK; HOWEVER, DUE TO THE PRESENCE OF BLOOD IN THE LOWER PART OF THE OXYGENATOR, IT WAS ASSUMED THAT THERE WAS BLOOD LEAKAGE DUE TO A BROKEN FIBER. THE DEVICE HISTORY RECORD FOR THE INFANT OXYGENATOR, LOT #9772003, 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. THE PRODUCTION DOCUMENTATION FOR THE EUROSETS INFANT OXYGENATOR, LOT #9772003, 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. UNDER ¿RISKS AND SIDE EFFECTS,¿ THE IFU LISTS POSSIBLE RISKS AND SIDE EFFECTS, INCLUDING BLOOD LEAKAGE (CAUSED BY MECHANICAL FAILURE). THESE ARE POTENTIAL SIDE EFFECTS OF ALL EXTRACORPOREAL BLOOD CIRCULATION SYSTEMS. THE IFU INCLUDES WARNINGS: THAT THE DEVICE IS INTENDED TO BE USED BY PROFESSIONALLY TRAINED PERSONNEL. THAT THE EXTRACORPOREAL CIRCULATION HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED BY QUALIFIED HEALTHCARE PROFESSIONALS THROUGHOUT THE PROCEDURE. 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. UNDER THE SECTION TITLED ¿DURING BYPASS¿, THE IFU INSTRUCTS THAT DURING THE ENTIRE PROCEDURE, ACCORDING TO GOOD PREFUSION PRACTICES, MONITOR THE INTEGRITY OF THE SYSTEM FOR LEAKS ABSENCE. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS NOT HARMED. THE REPLACEMENT OXYGENATOR WORKED WELL. THE PUMP SPEED WAS 2400 RPM, THE FLOW WAS 0.8 L/MIN, AND THE GAS FLOW WAS 0.5 L/MIN. THERE WAS A DIALYSIS FILTER BETWEEN THE PUMP AND THE OXYGENATOR. THE ACTIVATED CLOTTING TIME (ACT) WAS APPROXIMATELY 200. AFTER A COUPLE OF HOURS OF SUPPORT, THE PATIENT STARTED TO WAKE UP AND COUGH, AND THE INTENSIVE CARE NURSE NOTICED BLOOD DRIPPING FROM THE BOTTOM OF THE OXYGENATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEW HOURS AFTER STARTING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) TREATMENT, IT WAS NOTICED IN THE INTENSIVE CARE UNIT (ICU) THAT THE OXYGENATOR WAS DRIPPING BLOOD ON THE FLOOR. IT APPEARED THAT THERE WAS A CRACK IN THE OXYGENATOR. ACCORDING TO THE USER, NO TRAUMA OR IMPACT TO THE DEVICE HAD OCCURRED. THE OXYGENATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958846 STANDALONE PMP NEONATAL OXYGENATOR BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR EUROSETS S.R.L. EU5088 009772003 08052705496253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown