BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA

    MDR report key: 23693180 · Received December 2, 2025

    Report

    Report Number
    MW5179685
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ARVADA / LIVANOVA / SORIN GROUP ITALIA S.R.L
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WAS A SIGNIFICANT BLOOD LEAK FROM THE OXYGENATOR OF THE CARDIOPULMONARY BYPASS MACHINE CAUSING HEMODYNAMIC COMPROMISE AND BLOOD LOSS TO THE PATIENT DURING AN EMERGENCY OPEN HEART SURGERY. THE LEAKING OXYGENATOR REMOVED FROM SERVICE AND REPLACED WITH A FUNCTIONAL OXYGENATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912389 LIVANOVA OXYGENATOR, CARDIOPULMONARY BYPASS DTZ ARVADA / LIVANOVA / SORIN GROUP ITALIA S.R.L INSPIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male