BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 START P

    MDR report key: 17884296 · Received October 6, 2023

    Report

    Report Number
    9680841-2023-00037
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 8, 2023
    Report Date
    January 10, 2024
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DESPITE REQUESTED, NO FURTHER DETAILS RELATED TO THE DURATION AND SURGICAL PHASE OF OXYGENATOR CHANGE OUT WAS OBTAINED. NO VISUAL EVIDENCE SHOWING THE DEFECT WAS PROVIDED. HOWEVER, BASED ON INVESTIGATION RESULTS OF A PREVIOUS SIMILAR COMPLAINTS ANALYSIS, IT IS REASONABLE TO CONCLUDE THAT BLOOD DROPS POURED OUT OF THE INSIDE OF TEMPERATURE PROBE CONNECTION HOLDER. IN DETAILS, INVESTIGATION FOUND A SUB-OPTIMAL INTERFERENCE BETWEEN THE INNER METAL PIN AND THE CO-MOLDED ABS POLYMER THUS CAUSING THE DROP BY DROP LEAK. TO FURTHER REDUCE THE OCCURENCY, THE TEMPERATURE PROBE CONNECTION HOLDER ARE SORTED BEFORE ASSEMBLY. ANALYSIS OF LIVANOVA COMPLAINTS DATABASE REVEALED NO OTHER ANALOGUE CASE NOTIFIED FOR BATCH CONCERNED OF OXYGENATOR FROM THE MARKET. DHR VERIFICATION CONFIRMED THAT NOTICED DEVICE WAS MANUFACTURED BEFORE ABOVE MENTIONED SORTING. INVESTIGATION IS ON-GOING TO IDENTIFY ADEQUATE CORRECTIVE ACTIONS. THESE TYPE OF ISSUE CAUSES NEGLIGIBLE BLOOD LOSS AND THEREFORE 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. PATIENT INFORMATION WERE NOT PROVIDED. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 8 START P OXYGENATOR (CATALOG NUMBER 050712) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050712 IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(6). G.5. THE PRODUCT ITEM 050712 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. H.10. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN GERMANY. THE INVOLVED DEVICE HAS NOT BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. 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

    SORING GROUP ITALIA RECEIVED A REPORT A LEAK WAS SEEN FROM THE INSIRE OXYGENATOR TEMPERATURE PROBE. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270630 INSPIRE 8 START P OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 050712 2302270167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown