BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 10556767 · Received September 18, 2020

    Report

    Report Number
    3003752502-2020-04149
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 20, 2020
    Report Date
    May 11, 2021
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF A PLASMA LEAK COULD NOT BE CONCLUSIVELY CONFIRMED THROUGH THE SUBMITTED PHOTOGRAPH, AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE REPORT OF DECREASED CARBON DIOXIDE REMOVAL COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED PHOTO SHOWED A TOWEL ON THE GROUND WITH SOME BRIGHT-YELLOW LIQUID ABSORBED. A LEAK FROM THE OXYGENATOR GAS OUTLET PORT WAS UNABLE TO BE CONFIRMED THROUGH THE SUBMITTED PHOTOGRAPH. THE EUROSETS AMG PMP OXYGENATOR, LOT #6080206, WAS DISPOSED OF BY THE ACCOUNT AS THE PATIENT WAS COVID-19 POSITIVE. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) EXPLAINS THAT THE DEVICE IS INTENDED FOR USE IN ADULT SURGICAL PROCEDURES REQUIRING EXTRACORPOREAL GAS EXCHANGE SUPPORT AND BLOOD TEMPERATURE CONTROL FOR PERIODS OF UP TO 6 HOURS. CONTACT WITH BLOOD FOR A LONGER PERIOD OF TIME IS UNADVISABLE. THIS DOCUMENT WARNS THAT THE EXTRACORPOREAL CIRCULATION ALWAYS HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED. THE IFU ALSO CONTAINS INFORMATION ON BLOOD GAS MONITORING AND EXPLAINS HOW TO ADJUST THE RELEVANT PARAMETERS BASED ON THE PATIENT'S BLOOD GAS VALUES. THIS DOCUMENT ADDITIONALLY STATES THAT A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE DURING PERFUSION. IF PARTICULAR SITUATIONS OCCUR WHICH MAY LEAD THE PERSON RESPONSIBLE FOR PERFUSION TO DETERMINE THAT THE SAFETY OF THE PATIENT MAY BE COMPROMISED (INCLUDING INSUFFICIENT OXYGENATOR PERFORMANCE AND ABNORMAL BLOOD PARAMETERS), OXYGENATOR REPLACEMENT SHOULD BE PERFORMED PER THE IFU GUIDELINES. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) REV. 04, IS CURRENTLY AVAILABLE. UNDER THE SECTION TITLED, ¿INTENDED USE¿, THE IFU STATES THAT THE ¿A.M.G. MODULE PMP NO T.P. STERILE IS INTENDED FOR USE IN ADULT SURGICAL PROCEDURES REQUIRING EXTRACORPOREAL GAS EXCHANGE SUPPORT AND BLOOD TEMPERATURE CONTROL FOR PERIODS OF UP TO 6 HOURS¿ AND ALSO THAT THE DEVICE ¿IS INTENDED TO BE USED IN AN EXTRACORPOREAL PERFUSION CIRCUIT TO OXYGENATE AND REMOVE CARBON DIOXIDE FROM THE BLOOD AND TO COOL OR WARM THE BLOOD DURING ROUTINE CARDIOPULMONARY BYPASS PROCEDURES UP TO 6 HOURS IN DURATION. CONTACT WITH BLOOD FOR A LONGER PERIOD OF TIME IS UNADVISABLE.¿ UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING THE EXTRACORPOREAL CIRCULATION (ECC) A BACKUP OXYGENATOR IS NECESSARY AND ALSO WARNS THAT THE EXTRACORPOREAL CIRCULATION HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED. ALSO, UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT ¿BEFORE USING THE PRODUCT IT IS ADVISABLE TO CAREFULLY INSPECT IT. SHIPPING AND HANDLING COULD CAUSE STRUCTURAL AND FUNCTIONAL DAMAGE TO THE DEVICE.¿ UNDER THE SECTION TITLED, ¿BYPASS START¿, THE IFU CONTAINS A SUBSECTION ON BLOOD GAS MONITORING AND EXPLAINS HOW TO ADJUST THE RELEVANT PARAMETERS BASED ON THE PATIENT¿S BLOOD GAS VALUES. 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. THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, LOT #6080206, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS MADE IN THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DECREASED CARBON DIOXIDE REMOVAL WHICH RESULTED IN INCREASED SWEEP.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AMG PMP OXYGENATOR WAS CHANGED OUT DUE TO A PLASMA LEAK. THE OXYGENATOR WAS DISPOSED OF BECAUSE THE PATIENT WAS COVID-19 POSITIVE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016539 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 6080206

    Patients

    Seq Age Sex Outcome Treatment
    1