BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA OXYGENATOR

    MDR report key: 21210352 · Received January 22, 2025

    Report

    Report Number
    MW5165066
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 15, 2025
    Manufacturer
    SORIN GROUP ITALIA S.R.L
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OXYGENATOR FAILURE WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083655 LIVANOVA OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L 2408260203

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other