BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 11755604 · Received April 30, 2021

    Report

    Report Number
    3003752502-2021-00005
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 12, 2021
    Report Date
    July 30, 2021
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: 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 ¿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. EUROSETS CONFIRMED A FLOWING NOISE UPON PERFORMING A PRESSURE DROP TEST TO THE RETURNED EUROSETS AMG PMP OXYGENATOR. A SPECIFIC CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT WHEN PRIMING THE EUROSETS AMG PMP OXYGENATOR ON A CENTRIMAG CIRCUIT, A PREVIOUSLY UNHEARD ¿WHIRRING¿ SOUND FROM THE GAS ESCAPE PORT OF THE OXYGENATOR WAS HEARD. THE OXYGENATOR WAS REPLACED. THE EUROSETS OXYGENATOR, LOT NUMBER 6944908, 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; THE TEST VALUES COLLECTED DEMONSTRATED THAT THE DEVICE WAS COMPLIANT WITH THE TECHNICAL INVESTIGATION. A FLOWING NOISE WAS NOTED UPON PERFORMING THE PRESSURE DROP TEST. EUROSETS REVIEWED THE PRODUCTION DOCUMENTATION FOR THE OXYGENATOR LOT AND CONFIRMED THAT ALL TESTS FROM THE PRODUCTION PROCESS WERE COMPLIANT WITH THE TECHNICAL SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PRIMING THE AMG OXYGENATOR ON A CENTRIMAG CIRCUIT, THERE WAS A PREVIOUSLY UNHEARD WHIRRING SOUND FROM THE GAS EXIT PORT OF THE OXYGENATOR. THE AMG/PMP OXYGENATOR WAS TAKEN OUT OF SERVICE AND REPLACED WITH A NEW ONE. THIS OXYGENATOR WAS NEVER CONNECTED TO A PATIENT SO THERE WAS NO OXYGEN GOING TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647414 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 6944908

    Patients

    Seq Age Sex Outcome Treatment
    1