BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE OXYGENATOR

    MDR report key: 23776486 · Received December 11, 2025

    Report

    Report Number
    9680841-2025-900036
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 11, 2025
    Report Date
    April 8, 2026
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K180448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050703) IS REGISTERED IN THE USA (510(K) NUMBER: K180448). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H11: 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 RECEIVED A REPORT OF AN HIGH PRESSURE EXCURSION EVENT OCCURRED DURING CROSS CLAMP PHASE, WHILE USING AN INSPIRE 8F OXYGENATOR. PATIENT WAS COOLED AND BLOOD IN THE CIRCUIT WAS HAEMODILUTED, WITH NO PRESSURE DECREASE. SUBSEQUENTLY, EXTRA DOSE OF HEPARIN WAS PROVIDED, AND HIGH PRESSURE STILL PERSISTED. FINALLY, SURGEON DECIDED TO REMOVE CROSS CLAMP AND CHANGE OUT THE OXYGENATOR, AND THE PATIENT WAS VENTILATED DURING THE INTERVAL BETWEEN CROSS-CLAMP REMOVAL AND INSTALLATION OF THE NEW CIRCUIT. PROCEDURE WAS THEN RESUMED WITHOUT ANY FURTHER CONSEQUENCES. MECHANICAL VENTILATION OF PATIENT WAS CONSIDERED AS ADDITIONAL MEDICAL INTERVENTION INTENDED TO PREVENT OR PRECLUDE DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250009 INSPIRE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA INSPIRE 8F M (ASSEMBLED INTO CUSTOMIZED PERFUSION TUBING) 2508260168(INTOPTS:2507180082)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention