BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F

    MDR report key: 20988373 · Received December 20, 2024

    Report

    Report Number
    9680841-2024-00035
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 25, 2024
    Report Date
    May 28, 2025
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS REQUESTED BACK FOR INVESTIGATION. HOWEVER, BY FURTHER FOLLOW-UP, LIVANOVA WAS INFORMED THAT THE PRODUCT COULD NOT BE RETURNED IN MIRANDOLA FOR TESTING DUE TO THE PRESENCE OF RESIDUAL LIQUIDS INSIDE THE UNIT (THAT CAUSES THE DEVICE TO NOT BE AUTHORIZED TO TRAVEL ACCORDING TO LOCAL REGULATIONS). BASED ON THE DATA CURRENTLY AVAILABLE, AND ASSUMING THAT THE BLOOD COMPARTMENT WAS ALSO BEING PRIMED WHEN THE ISSUE OCCURRED, IT CANNOT BE EXCLUDED THAT THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS RELATED TO ANY OF THE BELOW: - AN UNINTENDED CHANGE OF THE PUMP ROTATION BY THE USER DURING THE PRIMING PHASE OF THE BLOOD SIDE; - AN IMPROPER OCCLUSION OF THE ROLLER PUMP THAT LED TO THE GENERATION OF AIR BUBBLES IN THE RESERVOIR-PUMP OUTLET TUBING LINE - A LOSS OF INTEGRITY OF THE BLOOD/WATER PATHWAYS OF THE DEVICE THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A.1. A.5. THERE WAS NO PATIENT INVOLVEMENT. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED IINSPIRE 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, FOR WHICH THE DEVICE IDENTIFIER IS (B)(6). G.5. THE PRODUCT ITEM: 050715CN IS NOT DISTRIBUTED IN THE USA, AND IT 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.11. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F. ACCORDING TO INFORMATION, DURING THE PRIMING OF THE INSPIRE OXYGENATOR, THE WATER FROM THE HEATER COOLER WAS SUCKED BACK (MOVED BACK) INTO BLOOD COMPARTMENT AND THE INSPIRE HVR RESERVOIR. A VIDEO OF THE CASE WAS PROVIDED, SHOWING THE REVERSE FLOW OF THE LIQUID INSIDE THE HVR. AS TROUBLESHOOTING, THE OXYGENATOR WAS REPLACED WITH A NEW ONE. A ROLLER PUMP SYSTEM WAS USED AND THE PUMP ROTATION WAS VERIFIED TO BE CORRECT. HOWEVER, IT WAS NOT SPECIFIED WHETHER ONLY THE WATER FLOW WAS ACTIVATED AT THE TIME OF FAILURE OR ALSO THE RE-CIRCULATION OF THE PRIME SOLUTION INTO THE BLOOD COMPARTMENT OF THE OXYGENATOR. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, THE PRIMING LIQUID PRIMED SUCKED AWAY BY THE HEATER-COOLER, IT WAS SUSPECTED LINE OF THE OXYGENATOR LEAKED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146347 INSPIRE 6F OXYGENATOR DTZ SORIN GROUP ITALIA 2408290067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown