BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE OXYGENATOR

    MDR report key: 23606999 · Received November 20, 2025

    Report

    Report Number
    9680841-2025-900035
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 22, 2025
    Report Date
    January 15, 2026
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K201916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 6F OXYGENATOR (CATALOGUE NUMBER 050715CN) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050715CN IS SIMILAR TO THE INSPIRE 6F OXYGENATOR 050715, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). G.5. THE PRODUCT ITEM 050715CN IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 6F COD.050715, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K201916). H11: LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED THAT THE INVOLVED OXYGENATOR DEVICE WAS NOT REPLACED AND THAT TAPE WAS APPLIED AT THE SEALING LEAKING POINT TO AVOID FURTHER PROBLEM. BASED ON SUCH ADDITIONAL INFORMATION, THE EVENT WAS RE-ASSESSED AS NOT REPORTABLE, SINCE NO DEVICE MALFUNCTION LIKELY TO RESULT IN PATIENT INJURY OR DEATH, EVEN IF IT RECURS, OCCURRED.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT OF AN INSPIRE 6F OXYGENATOR WHICH WAS NOT PROPERLY SEALED, CAUSING AIR LEAKAGE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609198 INSPIRE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA INSPIRE 6F 2506250166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown