BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 11637055 · Received April 8, 2021

    Report

    Report Number
    3003306248-2021-01091
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    March 12, 2021
    Report Date
    June 10, 2021
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED BLOOD LEAK COULD NOT BE CONFIRMED THROUGH THIS INVESTIGATION, AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO PHOTOS OF THE REPORTED LEAK WERE SUBMITTED FOR ANALYSIS. FURTHERMORE, A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS NOTED THAT THE PATIENT HAD COVID-19 AND WAS NOT ON ANTICOAGULATION AT THE TIME OF THE EVENT. THE EUROSETS AMG PMP INSTRUCTIONS FOR USE (IFU), REV. 04, 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 "DURING BYPASS" WARNS THAT THE ACT (ACTIVATED COAGULATION TIME) MUST ALWAYS BE LONGER THAN OR EQUAL TO 480 SECONDS IN ORDER TO ENSURE ADEQUATE ANTICOAGULATION OF THE EXTRACORPOREAL CIRCUIT. 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. THE PRODUCTION DOCUMENTATION FOR AMG PMP OXYGENATOR, WAS REVIEWED BY THE EXTERNAL MANUFACTURER (EUROSETS) AND SHOWED 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 THE ADVANCED MEMBRANE GAS EXCHANGE OXYGENATOR HAD BLOOD BREAKTHROUGH IMMEDIATELY AFTER SWITCH OUT. IMMEDIATELY AFTER IMPLANTING THE AMG OXYGENATOR ON THIS PATIENT, BLOOD BEGAN TO DRIP OUT OF THE EXHAUST PORT OF THE OXYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530657 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 6787007

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR