BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 7F

    MDR report key: 22313473 · Received June 24, 2025

    Report

    Report Number
    9680841-2025-900014
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 25, 2025
    Report Date
    October 21, 2025
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED D.4. THE INSPIRE 7F 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. G.5. THE COMPLAINED INSPIRE 7F OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND-ALONE OXYGENATOR (CATALOG NUMBER 050730) IS REGISTERED IN THE USA (510(K) NUMBER: K200683). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE INSPIRE 7F 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: THE REVIEW OF PUMP SHEET CONFIRMED REPORTED LOW VALUES OF OXYGEN PARTIAL PRESSURE (PO2). NO INFORMATION REGARDING GAS FLOW SETTINGS WERE PROVIDED. INVOLVED DEVICE WAS REQUESTED FOR INVESTIGATION AT MANUFACTURING SITE: NO BLOOD CLOTS OR BIOLOGICAL DEPOSITS WERE NOTICED ACROSS OXYGENATOR FIBERS, AND NO EVIDENT FIBERS DEVIATION OR BLOOD PATHWAY MALFUNCTION (SHUNTED AREAS) WERE IDENTIFIED. FUNCTIONAL GAS EXCHANGE PERFORMANCE TEST WAS PERFORMED, EVALUATING OXYGEN SATURATION (SAT%), HEMOGLOBIN CONCENTRATION (HB), PARTIAL PRESSURE OF OXYGEN (PO2) AND CARBON DIOXIDE (PCO2): NO FAILURE OF THE DEVICE TO PROVIDE ADEQUATE OXYGENATION LEVELS OF THE ARTERIAL BLOOD WAS REPRODUCED. INDEED, THE OUTPUT OF OXYGEN PARTIAL PRESSURE WAS FOUND WITHIN THE RANGE AS PROVIDED BY PRODUCT SPECIFICATION. THE OXYGEN TRANSFER WAS FOUND STABLE OVER TIME. OVERALL, THE INVOLVED OXYGENATOR PERFORMED PROPER OXYGENATION WITHOUT EXHIBITING ANY MAJOR ISSUE. THEREFORE, NO SPECIFIC MALFUNCTION OR DEVIATION OF THE DEVICE WAS CONFIRMED. REVIEW OF COMPLAINT DATABASE REVEALED NO FURTHER SIMILAR CASES FOR BATCH CONCERNED FROM THE MARKET, THUS EXCLUDING A SYSTEMATIC QUALITY ISSUE. NO CONCERNING TREND WAS IDENTIFIED EITHER. BASED ON ABOVE EVIDENCE, IT WAS REASONABLE TO ASSUME AS ROOT CAUSE OF THE EVENT A COMBINATION OF MULTIPLE FACTORS, SUCH AS THE SPECIFIC CLINICAL PROCEDURE, THE PATIENT CONDITIONS AND GAS-BLOOD SETTINGS, AND SO EXCLUDING ANY MALFUNCTION OF THE DEVICE. 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 THAT DURING A PROCEDURE, THE INSPIRE OXYGENATOR WAS CHANGED OUT. IN DETAILS: A THE BEGIN OF THE PROCEDURE THE TRANSMEMBRANE PRESSURE IS LOW (NEARLY 20MMHG WHILE NORMALLY IS 120MMHG). NO TROUBLESHOOTING ON EQUIPMENT OR ELECTRONIC. THE COMPETITOR GAS ANALYSIS SHOWS PO2 OVER 30 AND OXYGEN SATURATION IS 100%. PATIENT TEMPERATURE IS CLOSE TO 25°C DEGREES. GASSES FOR CALIBRATION OF COMPETITOR GAS ANALYSIS SHOWS, AS USUAL, THAT ARE INVALID MEASURING OF PO2, PCO2 AND PARTLY SATURATION, ESPECIALLY BY COOLING OF PATIENTS AND AT HYPOTHERMIC PROCEDURE. PO2 IS NOW 9 AND OXYGEN SATURATION IS 94%. FIO2 SET UP SEVERAL TIMES, PATIENT TEMPERATURE IS NOW 26°C DEGREES. COMPETITOR GAS ANALYSIS SHOWS PO2 OVER 20, AFTER CALIBRATIONS. CONTROL GASSES FROM OXY AND PATIENT SHOWS PO2 ON 9, 13 AND 15 EVEN AFTER MORE FIO2 AND IN THE END 75. OXYGEN SATURATION CANNOT BE INCREASED MORE THAN 94%. HOWEVER, WHEN THE PATIENT IS AT LOW TEMPERATURE, CUSTOMER EVALUATED THE OXYGEN SATURATION SHOULD BE 100% AND A PO2 OVER 65. MEDICAL TEAM ELECTED TO INTERRUPT THE PROCEDURE AND TO CHANGE OUT THE INSPIRE OXYGENATOR. CHANGE OUT OCCURS IN 4 MINUTES, WITH NO ISSUE AND NO CONSEQUENCES FOR THE PATIENT BECAUSE OF COOLING. ACCORDING TO CUSTOMER, THE INSPIRE DEVICE IS AVAILABLE AND THEY WERE USING OUR S5 AND GAS BLENDER.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064435 INSPIRE 7F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL INSPIRE 7F 2502250007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown