BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA INSPIRE M

    MDR report key: 10412903 · Received August 17, 2020

    Report

    Report Number
    10412903
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 13, 2020
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE PRIMING OF THE CARDIOPULMONARY BYPASS CIRCUIT IN PREPARATION FOR THE CASE, IT WAS NOTED THAT THERE WAS A LEAK COMING FROM ONE OF THE RECIRCULATION PORTS ON THE OXYGENATOR. WHILE WE WERE UNABLE TO DETERMINE WHAT WAS CAUSING THE LEAK, MANUFACTURER DEFECT COULD NOT BE RULED OUT. THE OXYGENATOR WAS SUBSEQUENTLY REPLACED BY A NEW ONE BEFORE CONTINUING TO PROCEED WITH CASE SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881005 LIVANOVA INSPIRE M OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 046006101 2003600026

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA