BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 7F M N/S

    MDR report key: 24385778 · Received February 19, 2026

    Report

    Report Number
    9680841-2026-900006
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 17, 2026
    Report Date
    April 1, 2026
    Manufacturer
    SORIN GROUP ITALIA - S.R.L.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5 PATIENT INFORMATION WAS NOT PROVIDED. D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE PRODUCT ITEM 03735 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 7 FM 050729 WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130209). H11 SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 7F M OXYGENATOR, THE EVENT OCCURRED IN CANADA. 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, IT WAS LEARNED THAT THE OXYGENATOR CHANGE OUT TOOK LESS THAN 3 MINUTES. BASED ON THE ABOVE, THE EVENT WAS RE-ASSESSED AS NOT REPORTABLE, SINCE PERFUSION INTERRUPTIONS LASTING LESS THAN 3 MINUTES DUE TO OXYGENATOR FAILURE, WITHOUT ANY PATIENT IMPACT AND NO MEDICAL INTERVENTIONS, COULD NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, EVEN IF RECUR.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT THAT THE OXYGENATOR INSPIRE 7F WAS CHANGED OUT DUE TO HIGH PRESSURE EXCURSION INSIDE THE MEMBRANE. NO PATIENT INJURY HAS BEEN REPORTED.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56124 INSPIRE 7F M N/S OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA - S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown