BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR INSPIRE 8

    MDR report key: 25126593 · Received May 8, 2026

    Report

    Report Number
    9680841-2026-900017
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. THE RESERVOIR OF THE INSPIRE 8F OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS (20JAN2028) TO THE STERILE FINISHED PRODUCT INTO WHICH THE RESERVOIR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). G.5. THE INVOLVED RESERVOIR INSPIRE 8F OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR AND RESERVOIR (CATALOG NUMBER: 050714) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K130433). H.4. THE DEVICE MANUFACTURE DATE (20JAN2026) REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE RESERVOIR WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE RESERVOIR OF THE INSPIRE 8F. THE INCIDENT OCCURRED IN BAY CITY, MICHIGAN, UNITED STATES. 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 THAT, HICK "SNOT-LIKE" SUBSTANCE WAS REPORTED IN THE INSPIRE 8 RESERVOIR EARLY INTO BYPASS. LATER, THE PERFUSIONIST REPORTED HAVING TO INCREASE RPMS IN AN ORDER TO MAINTAIN ADEQUATE FLOWS TO THE PATIENT. FLOWS RETURNED TO NORMAL ONCE A NEW CIRCUIT WAS CUT IN. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608510 RESERVOIR INSPIRE 8 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL INSPIRE HVR 2510120011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown