BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 8F

    MDR report key: 22588361 · Received July 24, 2025

    Report

    Report Number
    9680841-2025-900017
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    April 8, 2025
    Report Date
    September 19, 2025
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. 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. G.5. 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). 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 8F OXYGENATOR. ACCORDING TO LIVANOVA EVALUATION, INCREASED TRANSMEMBRANE PRESSURE DO NOT CREATE ANY PATIENT SERIOUS INJURY. HOWEVER, THE FLOW WAS LOW SO THE USE OF VASOPRESSORS IS NORMAL TO MAINTAIN MEAN ARTERIAL PRESSURE. THE INCREASE OF VASOPRESSOR IS NOT STANDARD PRACTISE, AND IT IS CONSIDERED AS AN UNEXPECTED MEDICAL INTERVENTION; IN THE ABSENCE OF THE INTERVENTION THERE WOULD BE NO CHANGE TO SUPPORT THE PATIENT WITH ADEQUATE FLOW. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    AVAILABLE UNIT WAS REQUESTED BACK TO LIVANOVA FACILITY FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED INSPIRE OXYGENATOR 8F HIGHLIGHTED THAT UNIT WAS STILL FILLED WITH BLOOD. DEVICE WAS THEREFORE EMPTIED, RINSED AND DRIED, AND SOME BLOOD RESIDUES COULD NOT BE TOTALLY REMOVED FROM THE INTEGRATED ARTERIAL FILTER AREA. UPON COMPLETION OF CLEANING PHASE, OXYGENATOR WAS FUNCTIONALLY TESTED AS PER DESIGN SPECIFICATIONS AND RELEVANT UNI. ADDITIONALLY, THE CUSTOMER RETURNED TO LIVANOVA A NON-USED INSPIRE OXYGENATOR FROM THE SAME LOT OF THE COMPLAINED OXY. ALSO THE NON-USED OXY WAS FUNCTIONALLY TESTED AS PER DESIGN SPECIFICATIONS AND RELEVANT UNI. LABORATORY TEST COULD NOT REPRODUCE ANY INCREASED PRESSURE DROP ACROSS THE OXYGENATORS: FIBERS WERE FOUND PATENT AND NOT OCCLUDED. NO MANUFACTURING WAS CONFIRMED. REVIEW OF LIVANOVA COMPLAINTS DATABASE IDENTIFIED NO FURTHER SIMILAR CASES NOTIFIED FOR CONCERNED BATCH, THUS A SYSTEMATIC QUALITY ISSUE CAN BE EXCLUDED. NO ADVERSE TREND RELATED TO THIS ISSUE HAS BEEN IDENTIFIED EITHER. THREE OTHER SIMILAR CASES (HIGH TRANSMEMBRANE PRESSURE) WERE REPORTED ON OTHER LOTS BY THE SAME CUSTOMER. BASED ON TESTING OUTCOME AND INVESTIGATION RESULTS OF PREVIOUS SIMILAR COMPLAINTS, THE REPORTED EVENT WAS REASONABLY TRACED BACK TO THE UNEXPECTED AND PROGRESSIVE BUILDUP OF BIOLOGICAL MATERIAL (PLATELET AGGREGATES AND FIBRIN MASS) INSIDE THE OXYGENATOR FIBERS DURING THE PROCEDURE. LIVANOVA CONDUCTED A LITERATURE AND TECHNICAL ANALYSIS ABOUT THE TRANS-MEMBRANE OXYGENATOR PRESSURE GRADIENTS. PRESSURE DROP EXCURSION ACROSS THE OXYGENATOR IS A KNOWN PHENOMENON REPORTED IN LITERATURE IN ALL MEMBRANE OXYGENATORS. THE MAIN CAUSE OF THE PRESSURE EXCURSION HAS BEEN IDENTIFIED IN THE PLATELET ACTIVATION AND ADHESION WITHIN THE OXYGENATOR THAT PROGRESSES TO INCREASE RESISTANCE TO BLOOD FLOW DURING CARDIOPULMONARY BYPASS. THE FACTORS INFLUENCING PRESSURE EXCURSIONS CAN BE ASSIGNED TO THREE MAIN AREAS: - SURGERY CLINICAL IMPACT - CPB CLINICAL IMPACT - PATHOLOGICAL PATIENT CONDITIONS RESEARCH ON THE PHENOMENON CONSISTENTLY CONCLUDES THAT THE PRESSURE EXCURSION IS COMPLEX AND MULTIFACTORIAL AND IN MOST OF THE CASES NONE OF THE FACTORS CONSIDERED SINGULARLY CAUSES THE PHENOMENON. AN ACCURATE ANALYSIS AND MONITORING OF THE FACTORS IDENTIFIED CAN LEAD TO THE REDUCTION OF THE PHENOMENON DURING CPB. NEVERTHELESS, AT CURRENT STATE OF KNOWLEDGE THE COMPLEX NATURE OF THE PHENOMENON DOES NOT ALLOW ITS COMPLETE ELIMINATION. 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

    THE COMPLAINED LOT OF OXYGENATORS 2503110102 (SN (B)(6)) WAS ASSEMBLED IN THE PTS CIRCUIT CODE IN01241 LOT 2502270150. SORIN GROUP ITALIA HAS RECEIVED A REPORT OF INCREASED TRANSMEMBRANE PRESSURE ACROSS INSPIRE OXYGENATOR ASSEMBLED INTO A CARDIOPULMONARY BYPASS CIRCUIT. ACCORDING TO CUSTOMER, PREMATURE DEGRADATION OF OXYGENATOR PERFORMANCE CAUSED INCREASE RESISTANCE TO FLOW, RESULTING IN MEASURES BEING TAKEN (REWARMING PATIENT, DECREASING FLOW, INCREASED USE OF VASOPRESSORS) TO SUSTAIN ADEQUATE PERFUSION PRESSURES AND MAINTAIN CARDIOPULMONARY BYPASS UNTIL THE SURGICAL PROCEDURE (CABGX5) WAS COMPLETED. THE PATIENT WAS WEANED SAFELY FROM BYPASS WITHOUT ANY RESIDUAL DEFICITS/HARM TO PATIENT NOR ANY NEED TO CHANGE OUT EQUIPMENT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188075 INSPIRE 8F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL INSPIRE 8F M 2503110102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown