BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F

    MDR report key: 21918512 · Received April 28, 2025

    Report

    Report Number
    9680841-2025-900005
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 3, 2025
    Report Date
    July 10, 2025
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE CURRENT EVENT WILL BE VOIDED SINCE IT IS A DUPLICATE OF A PREVIOUS ONE FOR WHICH REPORTING WAS ALREADY SUBMITTED (LIVANOVA REF. (B)(4), MW MANUFACTURER REPORT NUMBER 9680841-2025-900007).

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK ((B)(6), LOT NUMBER 2501280136) 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 HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND-ALONE OXYGENATOR (CATALOG NUMBER 050716) IS REGISTERED IN THE USA (510(K) NUMBER: K130433). 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 M HOLLOW FIBER OXYGENATOR. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT OF INCREASED TRANSMEMBRANE PRESSURE ACROSS INPIRE OXYGENATOR DURING A PROCEDURE. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY. THE CPB PUMP WAS PRIMED IN TYPICAL FASHION WITH 2 UNITS PRBCS, 700ML OF PLASMALYTE & 10K U HEPARIN. THE PRE-BYPASS CHECKLIST WAS COMPLETED. AN ACT OF 567 WAS ACHIEVED AND CARDIOPULMONARY BYPASS (CPB) WAS INITIATED WITHOUT ISSUE. CPB COURSE WAS UNEVENTFUL FOR THE FIRST 15 MINUTES. AFTER THIS POINT, AN INCREASED PRESSURE DIFFERENCE ACROSS THE INSPIRE OXYGENATOR THAT INDICATES HIGHER RESISTANCE WAS OBSERVED. THE OXYGENATOR WAS STILL FUNCTIONING WITH GOOD GAS EXCHANGE AT FLOWS EXCEEDING 5 L/MIN. PERFUSIONIST LOWERED THE FLOW/CARDIAC OUTPUT TO THE PATIENT STILL MAINTAINING ADEQUATE MAP AND OXYGEN DELIVERY. THE ACT WAS >480 SECONDS AND THEREFORE THE PERFUSIONIST ADMINISTERED 1000 IU OF ATIII AND 20K U HEPARIN AND INFORMED THE ANESTHETIST. THE GAS EXCHANGE AND FLOW ACROSS THE OXYGENATOR WAS ADEQUATE. THE PATIENT WAS REWARMED OF 1°C TO DECREASE THE VISCOSITY OF THE BLOOD (CPB INITIATED AT 34C, WARMED TO 35C). AN ADDITIONAL 30K U OF HEPARIN WAS ADMINISTERED. OVER THE COURSE OF THE NEXT HOUR, THE RESISTANCE ACROSS THE OXYGENATOR CONTINUALLY INCREASED, INHIBITING THE ABILITY OF THE ARTERIAL PUMP TO PROVIDE ADEQUATE FLOW AND OXYGEN DELIVERY. DURING THIS PERIOD, MULTIPLE CONSULTATIONS WERE HAD WITH PERFUSIONISTS AND THE ANESTHETIST TO OFFER SOLUTIONS AND 250ML OF 5% ALBUMIN WAS ADMINISTERED WHILE HEMOCONCENTRATION WAS INITIATED. WITH NO IMPROVEMENT IN OXYGENATOR RESISTANCE, THE DECISION WAS MADE TO DECREASE THE PATIENT'S CORE TEMPERATURE TO 30C AND INITIATE A PERIOD OF CIRCULATORY ARREST FOR OXYGENATOR CHANGE OUT. THE CIRCULATORY ARREST TIME WAS 3 MINUTES AND 36 SECONDS AT 29.5C, MEASURED BY NASOPHARYNGEAL TEMPERATURE. CARDIOPULMONARY BYPASS WAS INITIATED WITHOUT ISSUE; NO FURTHER COMPLICATIONS OCCURRED DURING THE INTRAOPERATIVE COURSE FROM A PERFUSION PERSPECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222808 INSPIRE 8F OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL INSPIRE 8F 2502110003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown