BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXYGENATOR

    MDR report key: 15156254 · Received August 3, 2022

    Report

    Report Number
    9680841-2022-00032
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 4, 2022
    Report Date
    September 26, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WERE NOT PROVIDED. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 6F CHINA (CATALOG NUMBER 050715CN, LOT 2109030010) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050715 IS SIMILAR TO THE INSPIRE 6F OXYGENATOR 050715, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4).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.10. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN GUANGDONG, CHINA. THE INVOLVED OXYGENATOR IS NOT AVAILABLE FOR INVESTIGATION. THROUGH FOLLOW-UP WITH THE CUSTOMER, LIVANOVA LEARNED THAT CHANGE-OUT WAS CONDUCTED DURING AORTIC CROSS-CLAMP APPLICATION AND LASTED APPROXIMATELY 15 MINUTES.NO CONSEQUENCES ON PATIENT'S HEALTH CONDITIONS WERE COMMUNICATED.IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : DEVICE NOT AVAILABLE

    Additional Manufacturer Narrative · 0

    THE COMPLAINED OXYGENATOR WAS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, PHOTOGRAPHIC EVIDENCE CONFIRMING THE LEAK FROM TEMPERATURE PROBE WERE PROVIDED. ANALYSIS OF LIVANOVA COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR CASE RELATED TO THE COMPLAINED LOT. DHR VERIFICATION FOUND THE LOT OF THE TEMPERATURE PROBE CONNECTOR WAS OBJECT OF AN INTERNAL INVESTIGATION TRIGGERED BY INCREASED LEAKING RATE. THE INVESTIGATION FOUND THAT, DUE TO A MOLD BALANCING ISSUE, THE CAVITY 3 OF THE MOLD WAS NOT CORRECTLY FILLED THUS CAUSING INCOMPLETE MOLD OF THE CONNECTOR AND EVENTUALLY THE REPORTED LEAKAGES. TO PREVENT REOCCURRENCE, A MOLD BALANCING ACTIVITY HAS BEEN COMPLETED. THE LOT OF THE COMPLAINED TEMPERATURE PROBE CONNECTOR WAS MANUFACTURED BEFORE ABOVE-DESCRIBED MOLD BALANCING ACTIVITY. SINCE THE RISK IS IN THE ACCEPTABLE REGION, NO OTHER CORRECTIVE ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING A OPEN-HEART BYPASS SURGERY ON A PATIENT WITH PULMONARY ATREXIA, THE INSPIRE 6F WAS USED. AFTER ABOUT 10 MINUTES OF USE, BLOOD LEAKAGE OCCURRED AT THE TEMPERATURE PROBE AT THE OUTLET OF THE OXYGENATOR BLOOD CIRCUIT. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719522 INSPIRE 6F HOLLOW FIBER OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2109030010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown