BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A.M.G. PMP PEDIATRIC STE CA

    MDR report key: 24715339 · Received March 30, 2026

    Report

    Report Number
    3003752502-2026-00012
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 27, 2026
    Manufacturer
    EUROSETS S.R.L.
    Product Code
    DTZ
    UDI-DI
    0008034013782020
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSUMPTIVE COAGULOPATHY APPEARED ALMOST IMMEDIATELY AFTER INITIATION OF EXTRACORPOREAL LIFE SUPPORT (ECLS) AND PERSISTED THROUGHOUT THE RUN, WHILE THERE WAS NO EVIDENCE OF COAGULOPATHY PRIOR TO ECLS. A REVIEW OF THE PATIENT'S CHART SHOWED MINIMAL IMPROVEMENT WITH CIRCUIT CHANGES, FOLLOWED BY RAPID RESOLUTION AFTER LIBERATION FROM ECLS. IT WAS NOTED THAT BASED ON THIS PATTERN, A CONCERN WAS RAISED OF WHETHER THIS IS LESS CONSISTENT WITH PRE-ECLS SYSTEMIC INFLAMMATORY CONSUMPTIVE PROCESS IN PATIENTS AND SUGGESTS A POSSIBLE CIRCUIT RELATED ISSUE. CIRCUIT CHANGE WAS DONE DUE TO BLEEDING AND CLOTTING WITH EUROSETS PEDIATRIC OXYGENATORS AND THE OXYGENATOR HAD BEEN DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619672 A.M.G. PMP PEDIATRIC STE CA OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. CA5087 011066700 0008034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention