BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 17980552 · Received October 20, 2023

    Report

    Report Number
    3003306248-2023-07165
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    September 21, 2023
    Report Date
    May 13, 2024
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K020271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION; HOWEVER, THE SUPPLIER OF THE OXYGENATOR (EUROSETS) DETERMINED THAT THERE WAS NO FAULT OF THE OXYGENATOR. THE EUROSETS INFANT OXYGENATOR, SERIAL NUMBER (B)(6), WAS RETURNED TO ABBOTT AND AN INITIAL VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE TO THE EXTERNAL HOUSING, PORTS, OR FIBERS. THERE WERE NO ABNORMALITIES NOTED. THE PRODUCTION DOCUMENTATION FOR THE EUROSETS AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) OXYGENATOR, LOT NUMBER 9230300, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. EUROSETS APPLIES THE 100% PRODUCTION PROCESS TEST TO ALL OF THEIR DEVICES. EUROSETS DETERMINED THE REPORTED VALUES ARE IN LINE WITH THE REFERENCE VALUES, AND BASED ON INFORMATION PROVIDED, THERE WAS NO FAULT OF THE DEVICE. THE PRODUCTION DOCUMENTATION FOR AMG PMP INFANT OXYGENATOR, LOT NUMBER 9230300, 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 INFANT OXYGENATOR INSTRUCTIONS FOR USE (IFU), REV. 00, IS CURRENTLY AVAILABLE. UNDER THE LIST OF WARNINGS, THE IFU WARNS THAT DURING USE, A SPARE OXYGENATOR MUST ALWAYS BE AVAILABLE AND ALSO WARNS THAT THE EXTRACORPOREAL CIRCULATION HAS TO BE CAREFULLY AND CONTINUOUSLY CHECKED BY QUALIFIED HEALTHCARE PROFESSIONALS THROUGHOUT THE PROCEDURE. THE IFU ALSO WARNS TO NOT USE THE PRODUCT IF, DURING PRIMING OR OPERATION, A VISUAL INSPECTION DETECTS THE PRESENCE OF AIR MICROBUBBLES/BUBBLES IN THE OXYGENATOR. UNDETECTED BUBBLES OR TOO LOW A LIQUID LEVEL IN THE RESERVOIR CAN CAUSE AIR EMBOLISM IN THE PATIENT. THESE CAN CAUSE GASEOUS EMBOLI TO THE PATIENT. UNDER THE SECTION TITLED, "PRIMING AND RECIRCULATION PROCEDURE", THE IFU CONTAINS INSTRUCTIONS ON HOW TO PURGE THE AIR FROM THE OXYGENATOR AND CIRCUIT. THIS SECTION WARNS THE USER TO REMOVE ALL THE AIR MICROBUBBLES/BUBBLES BEFORE STARTING THE EXTRACORPOREAL CIRCULATION. AIR ENTRAINMENT OR OXYGENATOR INCORRECT DE-AIRING MAY CAUSE AIR EMBOLI TO THE PATIENT AND CONSEQUENT SERIOUS INJURY OR DEATH. THIS SECTION ALSO WARNS THE PRESSURE LEVEL INSIDE THE BLOOD COMPARTMENT MUST NOT EXCEED 750 MMHG. THE IFU ALSO RECOMMENDS THE USE OF A BUBBLE TRAP OR FILTER ON THE ARTERIAL LINE TO REDUCE THE RISK OF EMBOLI TRANSMISSION TO THE PATIENT. 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 RISING PRESSURE WAS NOTED WHILE THE OXYGENATOR WAS SUPPORTING THE PATIENT. THE OXYGENATOR WAS EXCHANGED ON (B)(6) 2023. RISING PRESSURES WERE AGAIN NOTED ALONG WITH DECREASING FLOWS. THE OXYGENATOR WAS EXCHANGED ON (B)(6) 2023. RISING PRESSURES AND DECREASING FLOWS WERE AGAIN NOTED, AND THE CIRCUIT WAS EXCHANGED ON (B)(6) 2023. BOTH TIMES AFTER BLOOD FLOW WAS RE-INITIATED, A SHOWER OF AIR WAS NOTED DOWN THE VENOUS SIDE. THE OXYGENATORS HAD BEEN PRIMED AND DE-AIRED IN THE USUAL FASHION. THE PATIENT WAS ALIVE. FIRST OXYGENATOR MFR # 3003752502-2023-02399, SECOND OXYGENATOR MFR # 3003752502-2023-02400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955813 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DTZ EUROSETS S.R.L. 102953 9230300 08034013782020
    962070 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DTZ EUROSETS S.R.L. 102953 9230300 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female