BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.M.G.PMP PEDIATRIC

    MDR report key: 23756288 · Received December 9, 2025

    Report

    Report Number
    23756288
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 1, 2025
    Report Date
    November 5, 2025
    Manufacturer
    EUROSETS SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE ASSESSING THE ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] CIRCUIT AND OXYGENATOR, THE FIBERS IN THE OXYGENATOR WERE BRIGHT BLOODY FROM ? LEAKAGE FROM OUTSIDE OF THE FIBERS AND QUICKLY GROWING IN SURFACE AREA. TWO BLOOD CLOTS WERE NOTED WITHIN 30 MINUTES. PREVIOUSLY, THE OXYGENATOR FIBER WAS THEIR BASELINE COLOR, BLOODY WHITE. PICTURES OF OXYGENATOR WERE SENT TO THE PERFUSIONIST ON CALL AND OXYGENATOR WAS SHOWN TO THE PICU [PEDIATRIC INTENSIVE CARE UNIT] ATTENDING. PERFUSION SPOKE WITH PICU ATTENDING, CAME TO PATIENT'S ROOM TO VISUALIZE OXYGENATOR. MANY DISCUSSIONS WERE HAD WITH MULTIPLE PROVIDERS ABOUT OXYGENATOR. DECISION MADE TO CHANGE OUT ECMO CIRCUIT AROUND 0730. PATIENT REMAINED STABLE WITH STABLE ABGS [ARTERIAL BLOOD GAS] THROUGHOUT THE NIGHT. PERFUSION TO ISOLATE OXYGENATOR AFTER CIRCUIT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797500 A.M.G.PMP PEDIATRIC OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS SRL A.M.G.PMP PEDIATRIC STERILE

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female