BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 12623699 · Received October 13, 2021

    Report

    Report Number
    3003752502-2021-00011
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    September 15, 2021
    Report Date
    February 28, 2022
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE FLOW ISSUE COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE EUROSETS AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) OXYGENATOR, LOT NUMBER 7081108, WAS RETURNED TO THE ABBOTT FACILITY IN (B)(6), MA, WHERE A VISUAL INSPECTION WAS PERFORMED. SEGMENTS OF TUBING WERE SECURED TO THE BLOOD INLET AND BLOOD OUTLET PORTS WITH ZIP TIES AND PIGTAILS WERE SECURED TO BOTH THE BLOOD INLET AND OUTLET PORTS. A SEGMENT OF SCREEN TUBING WAS CONNECTED TO THE GAS INLET PORT. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE TO THE EXTERNAL HOUSING, PORTS, OR FIBERS. NO BLOOD WAS OBSERVED WITHIN THE TOP OR BOTTOM ORANGE HOUSING. THE PRODUCTION DOCUMENTATION FOR AMG PMP 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. 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 LIST OF PRECAUTIONS, THE IFU CAUTIONS THAT A STRICT ANTICOAGULATION PROTOCOL SHOULD BE FOLLOWED AND ANTICOAGULATION SHOULD BE ROUTINELY MONITORED DURING ALL PROCEDURES. THE BENEFIT OF EXTRACORPOREAL SUPPORT MUST BE WEIGHED AGAINST THE RISK OF SYSTEMIC ANTICOAGULATION AND MUST BE ASSESSED BY THE PRESCRIBING PHYSICIAN. ADEQUATE HEPARINIZATION MUST BE MAINTAINED BEFORE AND DURING BYPASS. 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.

    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

    THE ISSUE WITH THE OXYGENATOR OCCURRED IMMEDIATELY AFTER INITIATION OF SUPPORT. THE PATIENT HAD BEEN MINIMALLY HYPOXIC PRIOR TO INITIATING EXTRACORPOREAL LIFE SUPPORT (ECLS) WITH A DIFFERENT CANNULATION STRATEGY ON THE NEW CIRCUIT/ EUROSET. THE PATIENT WAS IN A HYPOXIC STATE DESPITE THE FIO2 ON THE VENT BEING INCREASED TO 100%. THE HYPOXEMIA BECAME WORSE ON THE NEW CIRCUIT/ EUROSET UNTIL THE EUROSET WAS CHANGED OUT. THE OXYGENATOR WAS EXCHANGED FOR ANOTHER EUROSETS OXYGENATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS PLACED ON EXTRACORPEAL MEMBRANE OXYGENATION (ECMO) IN THE CATHETERIZATION LAB. UPON INITIATION OF SUPPORT, THE PRE-OXYGENATION PRESSURES OF THE EUROSETS OXYGENATOR EXCEEDED 350 MMHG. DESPITE THIS, FLOW WAS UNABLE TO SURPASS 3.5 LITERS PER MINUTE, NO MATTER HOW HIGH THE CENTRIMAG¿S ROTATIONS PER MINUTE WERE INCREASED. PRESSURE ALARMS SOUNDED AND WERE ALSO DISPLAYED. THE EUROSETS OXYGENATOR WAS EXCHANGED AND SUPPORT TO THE PATIENT WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525520 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 7081108F0265 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention