BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 8F M

    MDR report key: 18442097 · Received January 4, 2024

    Report

    Report Number
    1718850-2024-01001
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    November 23, 2023
    Report Date
    December 6, 2023
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. G.5. THE DEVICE 050716 IS NOT REGISTERED IN USA AND IT IS SIMILAR TO OXYGENATOR (CATALOG NUMBER 050703) WHICH IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K180448). H.4. THE LOT OF THE DEVICE IS PENDING. THEREFORE ALSO THE MANUFACTURE DATE IS PENDING. INFORMATION WILL BE PROVIDED WHEN AVAIALABLE. H.10. LIVANOVA MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN SIENA, ITALY. LIVANOVA IS REQUESTING CONFIRMATION THE OXYGENATOR WAS CHANGED OUT DURING THE PROCEDURE. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, WHEN THE EXTRACORPOREAL CIRCULATION STARTED, HIGH TRANSMEMBRANE PRESSURES (237 MMHG AND ABOVE) WAS DETECTED AT THE INLET OF THE INSPIRE 8F OXYGENATOR. DRUGS WERE INFUSED AND THE PROBLEM WAS NOT RESOLVED. BLOOD CLOT WAS VISIBLE IN THE INTEGRATED FILTER OF THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615574 INSPIRE 8F M OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 050716 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention