BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE 7F

    MDR report key: 23026639 · Received September 11, 2025

    Report

    Report Number
    9680841-2025-900025
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    July 18, 2025
    Report Date
    September 11, 2025
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    UDI-DI
    08033178113350
    PMA / PMN Number
    K200683
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. H.11. LIVANOVA MANUFACTURES THE INSPIRE 7F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL. THE INCIDENT OCCURRED IN CANADA. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, LIVANOVA LEARNED THE FOLLOWING ADDITIONAL INFORMATION: - THE PATIENT DID NOT SUFFER FROM ANY KNOWN COAGULATION PATHOLOGY, HOWEVER HE WAS SEPTIC AS HAD A MITRAL ENDOCARDITIS. HE ALSO HAD A THROMBOCYTOSIS (HIGH PLATELET COUNT). - CUSTOMER CIRCUIT SETUP INCLUDED A PRE-OXYGENATOR PRESSURE SENSOR CONNECTED AT THE OUTLET OF ROLLER PUMP DRIVELINE, AND A POST-OXYGENATOR PRESSURE SENSOR CONNECTED ON THE ARTERIAL LINE; THE DIFFERENCE BETWEEN THE TWO GIVES THE DIFFERENTIAL PRESSURE INTERPRETED AS THE PRESSURE IN THE OXYGENATOR. - HIGH PRESSURE EXCURSION (HPE) WAS NOTICED AFTER 20 MINUTES OF BYPASS WITH A DIFFERENTIAL PRESSURE (DP) HIGHER THAN 200 MMHG. AS DP CONTINUED TO INCREASE, CUSTOMER HAD TO LOWER THE HEMATOCRIT (HCT) AND GAVE EPOPROSTENOL TO REDUCE PRESSURE INSIDE THE OXYGENATOR. LAST ACTION REDUCED SIGNIFICANTLY DP. THEN, AROUND 10000 - 70000NG OF A NON-SPECIFIED BOLUS WAS INFUSED (RATE OF 2 NG/KG/MIN). IN ADDITION, 400 U/KG OF HEPARIN WAS ADMINISTERED TO THE PATIENT FOR ANTICOAGULATION, FOR A TOTAL OF 75 000U IN THE WHOLE CASE. BASED ON LIVANOVA MEDICAL ASSESSMENT, THE PRE-EXISTING CONDITION OF THROMBOCYTOSIS (HIGH PLATELET COUNT "HPC") IN THE PATIENT HAS MOST LIKELY CAUSED THE PRESSURE EXCURSION OCCURRED, WHICH THEN RESULTED IN HEMOLYSIS. AN ADDITIONAL CONTRIBUTING FACTOR IS THAT THE PATIENT WAS SEPTIC AND THIS, TOGETHER WITH THE HPC, HAS LIKELY EXACERBATED THE PHENOMENON. HEMOLYSIS WAS REPORTEDLY A TEMPORARY CONDITION, SINCE THE CUSTOMER DID NOT REPORT ANY ADDITIONAL COMPLICATIONS FOLLOWING DRUGS ADMINISTRATION WHICH RESTORED BLOOD TO NORMAL CONDITION. THEREFORE, BASED ON THE ABOVE, THE HEMOLYSIS THAT OCCURRED ON THE PATIENT IS UNLIKELY RELATED TO THE INVOLVED OXYGENATOR AS WELL AS THE OBSERVED HPE. 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 ITALY RECEIVED A REPORT OF HIGH-PRESSURE EXCURSION EXPERIENCED DURING USAGE OF INSPIRE 7F OXYGENATOR. REPORTEDLY, HEMOLYSIS OCCURRED, AND DRUG WAS INJECTED TO THE PATIENT TO GET BACK TO NORMAL. THERE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231855 INSPIRE 7F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 2502220001 08033178113350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown