BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F

    MDR report key: 21785984 · Received April 7, 2025

    Report

    Report Number
    9680841-2025-900003
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    February 27, 2025
    Report Date
    May 15, 2025
    Manufacturer
    SORIN GROUP ITALY
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 6F OXYGENATOR (CATALOG NUMBER 050715CN) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050715CN IS SIMILAR TO THE INSPIRE 6F OXYGENATOR 050715, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130209). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. H.10. SORIN GROUP ITALY MANUFACTURES THE INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN CHINA. 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

    THROUGH FOLLOW-UP, LIVANOVA LEARNED THAT THE CLAIM WAS ACTUALLY RELATED TO THE OXYGENATION LEVELS OF THE ARTERIAL BLOOD OF THE PATIENT THAT SUDDENLY DROPPED DURING THE SURGERY. THE DECREASE IN THE GAS EXCHANGE PERFORMANCE OF THE DEVICE WAS DETECTED 140 MINUTES AFTER THE BEGINNING OF THE PROCEDURE AND ARTERIAL PO2 VALUE WAS 92 MMHG. AS TROUBLESHOOTING, MEDICAL TEAM RAISED THE GAS FLOW RATE TO 5 LPM AND THE FIO2 TO 100%. AT THIS POINT, A NEW BLOOD SAMPLE WAS TAKEN FROM THE ARTERIAL LINE SHOWING A PO2 VALUE OF 89 MMHG. HOWEVER, CONSIDERING THAT THE REDUCED GAS EXCHANGE PERFORMANCE WAS OBSERVED IN THE FINAL STAGE OF THE EXTRACORPOREAL CIRCULATION, NO CHANGE OUT OF THE UNIT WAS PERFORMED. THE AORTIC CROSS CLAMP WAS SHORTLY REMOVED, THE HEART OF THE PATIENT RESUMED BEATING AND THE OXYGENATION LEVELS OF THE PATIENT IMPROVED AFTER RESTORATION OF THE PATIENT'S OWN PULMONARY CIRCULATION. NO NEGATIVE CONSEQUENCES TO THE PATIENT OCCURRED. PART WAS NOT RETURNED FOR TESTING. REVIEW OF THE LIVANOVA COMPLAINTS DATABASE HIGHLIGHTED NO OTHER SIMILAR INCIDENTS NOTIFIED FOR THE BATCH CONCERNED FROM THE MARKET. CONSIDERING THE REPORTED TIME TO FAILURE, AND BASED ON THE REVIEW OF PREVIOUS SIMILAR EVENTS, IT IS REASONABLE TO CONCLUDE THAT THE PERFORMANCE OF THE OXYGENATOR STARTED TO DECLINE DUE TO THE UNEXPECTED ACTIVATION OF BLOOD AND SUBSEQUENT DEPOSITION OF BIOLOGICAL SUBSTANCES BETWEEN FIBERS, LEADING TO REDUCTION OF EFFECTIVE AREA TO PERFORM GAS EXCHANGE AND CONCOMITANT INCREASE OF GAS PATHWAY LENGTH TO PERFORM GAS EXCHANGE (ADVERSE EVENT PROCEDURE-RELATED). NO DEVIATION OR MALFUNCTION OF THE DEVICE MANUFACTURING-RELATED WAS THEREFORE ESTABLISHED. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET. SINCE NO DROP OF THE ARTERIAL PO2 VALUE BELOW 60 MMHG FOR MORE THAN 3 MINUTES DURING THE AORTIC CROSS CLAMP WAS CONFIRMED, NOR ANY CHANGE OUT OF THE PRODUCT WAS PERFORMED, THE EVENT HAS UNLIKELY POSSIBILITY TO CAUSE ANY PATIENT INJURY AND IS, THEREFORE, BEING REASSESSED AS NOT REPORTABLE.

    Description of Event or Problem · 0

    SORIN GROUP ITALY RECEIVED A REPORT OF A LOW OXYGENATION PRESSURE DURING THE PROCEDURE, WHILE USING AN INSPIRE 6F OXYGENATOR. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458346 INSPIRE 6F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALY INSPIRE 6F 2407200001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown