BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 13102452 · Received December 28, 2021

    Report

    Report Number
    3003752502-2021-00013
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 1, 2021
    Report Date
    May 25, 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
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE A FAILURE TO OXYGENATE COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE OXYGENATOR WAS NOT RETURNED FOR EVALUATION. THE PRODUCTION DOCUMENTATION FOR AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) OXYGENATOR, LOT NUMBER 007081108, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. BASED ONLY ON THE INFORMATION PROVIDED, THE SPECIFIC ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU) 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. 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. 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 BLOOD FLOW RATE WAS 5.5 LITERS PER MINUTE (LPM) AND THE GAS FLOW RATE WAS12 LPM WITH AN FRACTION OF INSPIRED OXYGEN ( FIO2 ) OF 100%. OXYGEN AND AIR WAS BLENDED WITH A GAS MIXER. THE ARTERIAL PARTIAL PRESSURE OF OXYGEN (PO2) WAS 160 MMHG AND THE ARTERIAL OXYGEN SATURATION (SO2) WAS 100%. THE VENOUS PO2 WAS 32 MMHG AND THE VENOUS SO2 WAS 54.5%. THE ACTIVATED CLOTTING TIME (ACT) WAS 199-207 SECONDS, AND THE PARTIAL THROMBOPLASTIN TIME (PTT) WAS 91.8 SECONDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OXYGENATOR FAILED TO OXYGENATE THE PATIENT WITHIN THE FIRST 12 HOURS OF USE. THE PATIENT WAS NOT A COVID-19 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997480 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 7081108 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male