BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGENATOR AND TUBING PACK KIT, ADULT

    MDR report key: 19707281 · Received July 9, 2024

    Report

    Report Number
    3003752502-2024-00022
    Event Type
    Death
    Date Received
    July 9, 2024
    Date of Event
    June 19, 2024
    Report Date
    September 18, 2024
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    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

    E1: REPORTER CONTACT INFORMATION WAS NOT AVAILABLE.   MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED BLOOD LEAK FROM THE OXYGENATOR WAS UNABLE TO BE CONFIRMED AS NO IMAGES OR PRODUCT WAS AVAILABLE FOR EVALUATION. A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, AND A DIRECT CORRELATION BETWEEN THE OXYGENATOR AND THE REPORTED OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE EUROSETS OXYGENATOR, LOT #9530602, WILL REPORTEDLY NOT RETURN FOR EVALUATION AS IT WAS DISPOSED OF. BASED ONLY ON THE AVAILABLE INFORMATION, EUROSETS (OXYGENATOR SUPPLIER/MANUFACTURER) WAS UNABLE TO IDENTIFY THE ROOT CAUSE OF THE PROBLEM. DEVICES ARE REQUIRED TO PASS MANUFACTURING INSPECTIONS AND SPECIFICATIONS PRIOR TO RELEASE, AND NO ABNORMALITIES WERE DOCUMENTED WHICH WOULD CAUSE OF CONTRIBUTE TO THE REPORTED OCCURRENCE. THIS DEVICE PASSED ALL REQUIRED TESTING. 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 THROUGH A SUPPLIER CORRECTIVE ACTION REQUEST. THE PRODUCTION DOCUMENTATION FOR THE EUROSETS OXYGENATOR, 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. THIS DOCUMENT LISTS POSSIBLE RISKS AND SIDE EFFECTS, INCLUDING DEATH, WHICH ARE THE POTENTIAL SIDE EFFECTS OF ALL EXTRACORPOREAL BLOOD CIRCULATION SYSTEMS. 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.¿ 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. IN THIS SECTION, THE IFU WARNS THAT ¿DURING CPB (CARDIOPULMONARY BYPASS) CHECK THE OXYGENATOR INTEGRITY, A SMALL BREACH CAN ALSO RESULT IN CONTINUOUS BLOOD LOSS, BACTERIAL RISK, VIRAL INFECTION OR PYROGEN REACTION. A LARGE BREACH CAN RESULT IN RAPID BLOOD LOSS LEADING TO SHOCK AND DEATH. IF LEAKAGE OCCURS REPLACE THE OXYGENATOR WITH A NEW ONE.¿ 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 AN OXYGENATOR THAT WAS PART OF THE ADULT OXYGENATOR KIT HAD A LEAK. THE TEAM HAD TO ASSEMBLE THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) QUICKLY AND DID NOT NOTICE THE LEAK DURING PRIMING. THE LEAK WAS NOTICED RIGHT AFTER STARTING PATIENT SUPPORT BY ECMO, AND THE LEAK WAS SOURCED FROM THE BOTTOM PART OF THE MEMBRANE CLOSE TO THE BLOOD INLET. THE OXYGENATOR WAS FUNCTIONING AT NORMAL PARAMETERS. THE OXYGENATOR WAS EXCHANGED. THE PATIENT ULTIMATELY PASSED AWAY, BUT THE DEATH WAS NOT RELATED TO THIS ISSUE. THE PATIENT'S DEATH WAS CAUSED BY OTHER REASONS NOT RELATED TO ECMO THERAPY. THE TEAM WAS HESITANT TO USE THE OXYGENATORS AS THIS WAS THE SECOND TIME THIS OCCURRED IN THE HOSPITAL THE FIRST TIME THE OXYGENATOR WAS REPORTED AT THE HOSPITAL IS COVERED UNDER MFR 3003752502-2024-00014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349427 OXYGENATOR AND TUBING PACK KIT, ADULT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. 14AG70131 009530602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death