BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 8F M

    MDR report key: 22902753 · Received August 27, 2025

    Report

    Report Number
    9680841-2025-900022
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 31, 2025
    Report Date
    March 5, 2026
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A1 TO A5: PATIENT INFORMATION WAS NOT PROVIDED. D4: THE INSPIRE 8F M OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G5: THE COMPLAINED INSPIRE 8F OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND-ALONE OXYGENATOR (CATALOG NUMBER 050703) IS REGISTERED IN THE USA (510(K) NUMBER: K180448). H4: THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H11: LIVANOVA MANUFACTURES THE OXYGENATOR. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: A REVIEW OF THE COMPLAINTS DATABASE IDENTIFIED NO OTHER SIMILAR INCIDENTS NOTIFIED FOR THE BATCH CONCERNED FROM THE MARKET, INDICATING THAT THIS IS A UNIQUE EVENT. VERIFICATION OF THE PRODUCTION RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED AND RELEASED IN COMPLIANCE WITH THE SPECIFICATION SAND QUALITY REQUIREMENTS. THE AFFECTED DEVICE WAS DISCARDED, AND THE PUMP SHEET OF THE CASE WAS NOT PROVIDED FOR ANALYSIS. BASED ON THE AVAILABLE INFORMATION, THE RAPID NORMALIZATION OF BLOOD GAS VALUES AFTER DISCONTINUATION OF BYPASS INDICATES THAT THE ELEVATED PCO2 WAS REASONABLY RELATED TO INCREASED INTRAOPERATIVE CO2 LOAD, LIKELY INFLUENCED BY HIGH CO2 INSUFFLATION RATES, RATHER THAN A DEVICE-RELATED ISSUE. FURTHERMORE, THE INSTRUCTIONS FOR USE (IFU) OF THE DEVICE CLEARLY STATE THAT, WHEN CO2 FLOODING IS APPLIED TO THE OPERATING FIELD, AN INCREASE IN ARTERIAL PCO2 MAY BE OBSERVED, AND THAT ADJUSTMENTS TO THE GAS FLOW TO THE OXYGENATOR MAYBE REQUIRED ACCORDINGLY, WHILE NOT EXCEEDING A GAS-TO-BLOOD FLOW RATIO OF 2:1. IN THIS CASE, NO INFORMATION REGARDING THE APPLIED BLOOD FLOW RATE WAS PROVIDED, LIMITING FURTHER ASSESSMENT OF GAS-TO-BLOOD FLOW RATIO COMPLIANCE. CONSIDERING ALL THE ABOVE FACTS, IT CANNOT BE EXCLUDED THAT THE USE OF CO2 FLOODING IN THE OPERATING FIELD MAY HAVE CONTRIBUTED TO THE REDUCED CO2 REMOVAL OBSERVED DURING THE PROCEDURE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT OF POOR CO2 REMOVAL DURING A PROCEDURE USING AN INSPIRE 8F OXYGENATOR. MEDICAL TEAM REQUIRED A LARGE SWEEP GAS (HIGHEST 9.5 L/MIN) TO REDUCE THE HIGH PCO2. HOWEVER, IT DIDN'T REDUCE MUCH PAST 7.9KPA WITH PH 7.25. MEDICAL TEAM REDUCED SUCTION AND CO2 INSUFFLATION. MEDICAL TEAM ELECTED TO EXIT BYPASS AS THE SITUATION STABILIZED AND THE OXYGENATION WAS EFFECTIVE. EVEN AFTER THE CROSS CLAP WAS REMOVED AND VENTILATION WAS STARTED, PCO2 WAS HIGH. ACCORDING TO CUSTOMER, THE FIRST PATIENT GAS POST-PUMP WAS NORMAL WITH A PCO2 OF 5 KPA AND PH 7.4. THERE IS NO REPORT OF ANY PATIENT INJURY. LIVANOVA HAS CONSERVATIVELY REPORTED THE PRESENT EVENT AS AN ADDITIONAL MEDICAL INTERVENTION. HOWEVER, THE ISSUE WAS UNLIKELY RELATED TO PRODUCT MALFUNCTION SINCE ALSO WITH VENTILATION PCO2 REMAINED HIGH.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055709 INSPIRE 8F M OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA INSPIRE 8F M 2504190003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown