BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 11788273 · Received May 6, 2021

    Report

    Report Number
    3003752502-2021-00006
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 29, 2021
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, LOT NUMBER 6944908, WAS REVIEWED BY THE EXTERNAL MANUFACTURER 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, ¿PRIMING AND RECIRCULATION PROCEDURE¿, THE IFU PROVIDES INSTRUCTIONS ON HOW TO PRIME THE OXYGENATOR FOR USE INCLUDING VERIFYING THE INTEGRITY OF THE HEAT EXCHANGER AND PAYING PARTICULAR ATTENTION TO POSSIBLE WATER LEAKS. THIS SECTION FURTHER WARNS THAT THE ¿PRESSURE LEVEL INSIDE THE BLOOD COMPARTMENT OF THE OXYGENATING MODULE SHALL NOT EXCEED 100 KPA (1 BAR / 14 PSI)¿ AND THAT THE ¿BLOOD SIDE COMPARTMENT PRESSURE MUST BE HIGHER THAN THE GAS SIDE COMPARTMENT PRESSURE¿. ADDITIONALLY, THIS SECTION STATES THAT THE OXYGENATOR SHOULD BE PRIMED BY GRAVITY. THE IFU PROVIDES FURTHER INSTRUCTIONS ON HOW TO OPEN THE ARTERIAL LINE, HOW TO PURGE THE AIR CONTAINED IN THE CIRCUIT, HOW TO CLOSE THE PURGING LINE, AND HOW TO CLOSE THE VENOUS AND ARTERIAL LINES IN THIS SECTION. 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 REPORTED LEAK DURING PRIMING COULD NOT BE CONFIRMED THROUGH THIS INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO PHOTOS OF THE REPORTED LEAK WERE SUBMITTED FOR ANALYSIS. FURTHERMORE, A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION, INCLUDING DEVICE RETURN STATUS, WERE SENT TO THE CUSTOMER. HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE EUROSETS AMG PMP OXYGENATOR, LOT NUMBER 6944908, WAS NOT RETURNED FOR INVESTIGATION AND NO PHOTOS OF THE REPORTED LEAK WERE SUBMITTED FOR ANALYSIS. THEREFORE, A SPECIFIC CAUSE FOR THE REPORTED BLOOD LEAK COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRIMED AN OUT OF THE PACKAGE ADVANCED MEMBRANE GAS EXCHANGE OXYGENATOR. ONCE PRIMED, THE PERFUSIONIST NOTICED FLUID LEAKING FROM THE INLET PORT. THE PERFUSIONIST TOOK THE OXYGENATOR OUT OF THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT AND PUT A NEW ONE IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684655 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 6944908 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1