BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F DUAL

    MDR report key: 24018736 · Received January 9, 2026

    Report

    Report Number
    9680841-2026-900001
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 10, 2025
    Report Date
    April 23, 2026
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE EVENT WAS CONFIRMED VIA PHOTOGRAPHIC EVIDENCE. COMPLAINTS DATABASE REVIEW REVEALED NO FURTHER SIMILAR EVENTS FOR IMPACTED BATCH LOT. NO CONCERNING TREND WAS HIGHLIGHTED FOR REPORTED FAILURE MODE. BASED ON THE INVESTIGATION FINDINGS AND CONSIDERING THAT ALL UNITS ARE LEAK-TESTED IN THE MANUFACTURING LINE TO CONFIRM WELDING INTEGRITY BEFORE RELEASE, THE ROOT CAUSE OF THE REPORTED EVENT COULD BE TRACED BACK TO ONE OF THE FOLLOWING: - RESERVOIR WELDING THAT DRIFTED OVER TIME REASONABLY, DUE TO FURTHER THERMAL AND MECHANICAL STRESSES/ROUGH HANDLING AFTER PRODUCT RELEASE; - ISOLATED TRANSPORT DEVIATION. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A1-A5 PATIENT INFORMATION WAS NOT PROVIDED D.4.THE COMPLAINED INSPIRE 8F DUAL OXYGENATOR (CATALOG NUMBER 050720CN) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050720CN IS SIMILAR TO THE INSPIRE 8F DUAL OXYGENATOR 050720, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). G.5. THE PRODUCT ITEM 050720CN IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO 050720, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K121909. H11 SORIN GROUP ITALIA MANUFACTURES THE IINSPIRE 8F DUAL OXYGENATOR, THE ISSUE OCCURRED IN CHINA. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT INDICATING THAT, DURING CARDIOPULMONARY BYPASS USING THE INSPIRE 8F DUAL SYSTEM, PRESSURE OF 0¿3 MMHG WAS DETECTED WITHIN THE BLOOD RESERVOIR. REPEATED CHECKS OF THE VACUUM SOURCE, VACUUM CONTROLLER, AND ASSOCIATED TUBING CONFIRMED NORMAL FUNCTIONALITY. UPON DISCONNECTING THE SUCTION TUBE FROM THE BLOOD RESERVOIR TANK, NEGATIVE PRESSURE WITHIN THE TUBE WAS VERIFIED. SUSPECTING A COMPROMISED SEAL INTEGRITY OF THE RESERVOIR TANK, THE UPPER RIM WAS SEALED USING STERILE SURGICAL FILM. FOLLOWING THIS INTERVENTION, THE PRESSURE WITHIN THE RESERVOIR DECREASED TO ¿25 MMHG, ALIGNING WITH THE SET PRESSURE ON THE VACUUM CONTROLLER. SURGEON DECIDED TO CHANGE AFFECTED DEVICE, WITH NO PATIENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516998 INSPIRE 8F DUAL RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN SORIN GROUP ITALIA INSPIRE 8F DUAL 25052100001

    Patients

    Seq Age Sex Outcome Treatment
    1