BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 14429413 · Received May 18, 2022

    Report

    Report Number
    3003752502-2022-00001
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 27, 2022
    Report Date
    July 20, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EUROSETS CONFIRMED AN AUDIBLE FLOWING NOISE UPON PERFORMING A PRESSURE DROP TEST TO THE RETURNED EUROSETS AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) OXYGENATOR. A SPECIFIC ROOT CAUSE FOR THE NOISE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE EUROSETS OXYGENATOR, LOT NUMBER 7383208, WAS RETURNED TO ABBOTT AND AN INITIAL VISUAL INSPECTION WAS PERFORMED. VISUAL INSPECTION OF THE OXYGENATOR REVEALED NO OBVIOUS DAMAGE OR ABNORMALITIES. THE OXYGENATOR WAS FORWARDED TO THE EXTERNAL MANUFACTURER (EUROSETS) FOR TECHNICAL ANALYSIS. THE OXYGENATOR WAS SET UP AND A PRESSURE DROP TEST WAS PERFORMED WITH THE FLOW NOISE CLEARLY AUDIBLE. THE RECORDED PRESSURE VALUES WERE COMPLIANT WITH THE TECHNICAL INVESTIGATION. EUROSETS REVIEWED THE PRODUCTION DOCUMENTATION FOR THE OXYGENATOR LOT AND CONFIRMED ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. EUROSETS CONFIRMED THAT THEY APPLY 100% PRODUCTION PROCESS TESTS TO ALL OF THEIR DEVICES. EUROSETS IS STILL INVESTIGATING THE ROOT CAUSE OF THIS KIND OF ISSUE. THE EUROSETS AMG (ADVANCED MEMBRANE GAS EXCHANGE) PMP (POLYMETHYLPENTENE) 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.¿ THE SECTION ENTITLED ¿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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE OXYGENATOR WAS BEING PRIMED, IT MADE A LOUD WHISTLE NOISE. THE HIGHER THE SPEED, THE LOUDER THE NOISE WAS. THE TEAM RAN AN ARTERIAL BLOOD GAS (ABG) ON CRYSTALLOID AND THE PO2 WAS > 600. THE GASES WERE WITHIN NORMAL LIMITS. THE TEAM DECIDED NOT TO TAKE A CHANCE WITH THE OXYGENATOR AND SENT IT BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501852 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 7383208F0006 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown