BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M

    MDR report key: 18433541 · Received January 3, 2024

    Report

    Report Number
    9680841-2024-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    November 28, 2023
    Report Date
    April 16, 2024
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). G.5. THE INVOLVED INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050703) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K180448). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H.10. SORIN GROUP ITALIA MANUFACTURES THE K180448. THE INCIDENT OCCURRED IN FRANCE. CURRENT STATE OF THE PATIENT: NO CLINICAL CONSEQUENCES ON THE PATIENT BECAUSE IMMEDIATE TREATMENT BY THE HEALTHCARE TEAM. ACTIONS TAKEN IN THE HEALTHCARE ESTABLISHMENT FOR PATIENT CARE: INCREASE IN O2 FLOW. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    INCREASE THE FIO2 LEVEL IS THE SOLUTION RECOMMENDED BY IFU IF LOW PO2 VALUES ARE MEASURED IN THE PATIENT'S ARTERIAL BLOOD, THEREFORE IT CAN BE CONCLUDED THAT DEVICE RESPONDED PROPERLY TO THE APPLIED COUNTERMEASURE. NO DEVICE MALFUNCTION WAS CONFIRMED ACCORDINGLY. REVIEW OF LIVANOVA COMPLAINTS DATABASE IDENTIFIED NO FURTHER SIMILAR CASES NOTIFIED FOR CONCERNED BATCH, OUT OF (B)(4) TOTAL MANUFACTURED UNITS, THUS A SYSTEMATIC QUALITY ISSUE CAN BE EXCLUDED. NO ADVERSE TREND RELATED TO THIS ISSUE HAS BEEN IDENTIFIED EITHER. DESPITE SEVERAL ATTEMPTS PERFORMED, NO ADDITIONAL INFORMATION ABOUT BLOOD GAS VALUES, INITIAL FLOW SETTINGS, DETAILED TROUBLESHOOTING AND DURATION OF LOW OXYGENATION CONDITION WAS PROVIDED. BASED ON LIMITED DATA AVAILABLE, THE SPECIFIC ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CLEARLY DETERMINED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT AND IMPACTING THE INVESTIGATION RESULTS IS RECEIVED, THIS COMPLAINT FILE WILL BE RE-OPENED AND UPDATED. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA HAS RECEIVED A REPORT THAT THERE WAS A DESATURATION IN THE ARTERIAL LINE DESPITE SUPPLYING THE OXYGENATOR WITH O2. THE ISSUE OCCURRED WHEN STARTING CEC. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549380 INSPIRE 8F M OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 03705PTS 2310100231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown