BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE OXYGENATOR

    MDR report key: 24506742 · Received March 4, 2026

    Report

    Report Number
    9680841-2026-900009
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 4, 2026
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K201916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED INSPIRE 6F 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 (CATALOGUE NUMBER 050702) IS REGISTERED 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.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT OF AN INSPIRE OXYGENATOR 6F WHICH CLOTTED DURING PROCEDURE. AS TROUBLESHOOTING, THE OXYGENATOR WAS CHANGED OUT, AND REPLACEMENT REQUIRED 5 MINUTES TO BE COMPLETED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141243 INSPIRE OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA INSPIRE 6F M N/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown