BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 8F

    MDR report key: 23478548 · Received November 5, 2025

    Report

    Report Number
    1718850-2025-10011
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 2, 2025
    Report Date
    November 5, 2025
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. THE INSPIRE 8F OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS (07JUL2027) TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE PERFUSION SYSTEM PACK IS (B)(4). G.5. THE INVOLVED INSPIRE 8F OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A PERFUSION SYSTEM PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050703) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K180448). H.4. THE DEVICE MANUFACTURING DATE (07JUL2025) REFERS TO MANUFACTURING DATE OF THE STERILE, FINISHED PERFUSION SYSTEM PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE INSPIRE 8F. THE INCIDENT OCCURRED IN UNITED STATES. 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, DURING BYPASS ON CABG PROCEDURE, INSPIRE 8F OXYGENATOR WAS NOT PERFORMING AS EXPECTED AS THE PATIENT ARTERIAL BLOOD WAS AS DARK AS THE VENOUS BLOOD. THE ANESTHESIOLOGIST STARTED VENTILATING THE PATIENT, MEDICAL TEAM CAME OFF BYPASS AND COMPLETED THE PROCEDURE AS AN OPCABG. AT THE END OF THE CASE, PERFUSIONIST NOTICED THAT PATIENT ARTERIAL BLOOD WAS BRIGHT RED AGAIN SUGGESTING THAT OXYGENATOR WAS WORKING PROPERLY. MEDICAL TEAM DID NOT NEED TO GO BACK ON BYPASS. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692918 INSPIRE 8F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA INSPIRE 8F 2505300115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown