BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 13110439 · Received December 29, 2021

    Report

    Report Number
    3003752502-2021-00014
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    December 11, 2021
    Report Date
    May 3, 2022
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED IMAGES CONFIRMED THE REPORT OF BLOOD LEAKING FROM THE GAS OUTLET PORT. THE OXYGENATOR WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, A SPECIFIC CAUSE FOR THE BLOOD LEAKAGE COULD NOT BE CONCLUSIVELY DETERMINED. THE PRODUCTION DOCUMENTATION FOR AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) OXYGENATOR, LOT 7081108, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. ACCORDING TO EUROSETS, THE REPORTED LEAK COULD HAVE RESULTED FROM DAMAGE TO A FIBER THAT OCCURRED AT SOME POINT FOLLOWING THE MANUFACTURING AND TESTING PHASES; HOWEVER A SPECIFIC CAUSE FOR THE REPORTED BLOOD LEAK COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, LOT NUMBER 7081108, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. 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 ¿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.

    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 THE PATIENT WAS BEING SUPPORTED BY AN OXYGENATOR. THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SETTINGS WERE AS FOLLOWS: 4000 RPMS, 4.2 LS. THE BLENDER SETTINGS WERE 100% FIO2 AND 3L SWEEP. CHANGES HAD NOT BEEN MADE TO THE SETTINGS WHEN FRANK BLOOD BUBBLES WERE NOTED TO BE COMING FROM THE GAS OUTLET PORT. THE OXYGENATOR WAS THEN EXCHANGED. NO ALARMS WERE REPORTED. ONE HOUR FOLLOWING THE EXCHANGE THERE HAD NOT BEEN ANY CHANGES TO THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006341 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 7081108F0319 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male