BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    MDR report key: 24717632 · Received March 30, 2026

    Report

    Report Number
    3003752502-2026-00011
    Event Type
    Malfunction
    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

    SECTION D4: EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. 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 PATIENT HAD CONSUMPTIVE COAGULOPATHY WHICH 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 ALSO SHOWED MINIMAL IMPROVEMENT WITH CIRCUIT CHANGES, FOLLOWED BY RAPID RESOLUTION AFTER LIBERATION FROM ECLS. BASED ON THIS PATTERN, IT RAISED THE QUESTION OF WHETHER THIS WAS LESS CONSISTENT WITH A PRE ECLS SYSTEMIC INFLAMMATORY CONSUMPTIVE PROCESS AND MORE SUGGESTIVE OF A POSSIBLE CIRCUIT RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407248 ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE OXYGENATOR, CARDIOPULMONARY BYPASS DTZ EUROSETS S.R.L. CA5062 11066700F0014 0008034013782020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention