BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F

    MDR report key: 23401936 · Received October 28, 2025

    Report

    Report Number
    9680841-2025-900029
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 26, 2025
    Report Date
    February 27, 2026
    Manufacturer
    SORIN GROUP ITALIA - S.R.L.
    Product Code
    DTZ
    UDI-DI
    38033178113633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H.11. THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED THE EVENT INVOLVED FLUID LEAKAGE DURING THE PRIMING PHASE OF THE PROCEDURE, THUS BEFORE INITIATING THE BYPASS PROCEDURE. BASED ON THE ABOVE, THE EVENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH, EVEN IF REOCCURRED, INDEED IT CAN ALWAYS BE RECOGNIZED PRIOR TO START PROCEDURE, ENSURING NO RISK TO PATIENT SAFETY OR DEVICE PERFORMANCE. CONSEQUENTLY, THE EVENT HAS BEEN ASSESSED AS NON-REPORTABLE. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A1-A5 PATIENT INFORMATION WAS NOT PROVIDED. G.5. THE PRODUCT ITEM 050715CN IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 6F OXYGENATOR 050715, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). H11 SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F, THE EVENT 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 ITALY RECEIVED A REPORT THAT, DURING PROCEDURE, AN INSPIRE 6F OXYGENATOR LEAKED AT THE CONNECTION POINT OF THE INFUSION LINE. MEDICAL STAFF ELECTED TO CHANGED OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2420079 INSPIRE 6F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA - S.R.L. INSPIRE 6F 2504240002 38033178113633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown