BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 22161800 · Received June 6, 2025

    Report

    Report Number
    3003752502-2025-00019
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 7, 2025
    Report Date
    June 6, 2025
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    08034013782020
    PMA / PMN Number
    K141492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A - ALL THE KNOWN PATIENT INFORMATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS BLOOD EXPELLED FROM THE AMG OXYGENATOR GAS EXHAUST WHEN SIGHING. THIS WAS INITIALLY BLOOD TINGED WATER, HOWEVER OVER TWO DAYS THEN EVOLVED TO RED BLOOD WHEN SIGHING THE OXYGENATOR. THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT WAS THEN EXCHANGED. THE TROUBLESHOOTING THAT WAS PERFORMED WAS HEATER/COOLER (HTP 1500) WAS CHECKED FOR BLOOD. THERE WAS NO VISIBLE BLOOD. WHEN WATER LINES WERE REMOVED THE WATER RAN CLEAR. THE PRE AND POST OXY GASES WERE WITHIN NORMAL LIMITS. SINCE THE PATIENT WAS UNSTABLE THE CHANGEOUT WAS DEFERRED AFTER WEIGH RISKS AND BENEFITS. THERE WERE NO CIRCUIT CONFIGURATIONS OR CUT-INS. ANTICOAGULATION WAS BEING USED. ACTIVATED CLOTTING TIME (ACT) WAS 147. THE SWEEP GAS WAS 4 LPM @100%. THE CHANGE IN PRESSURE WAS 50MMHG. THERE WERE NO MEDICATIONS THROUGH THE OXYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618925 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. US5062 08034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male