BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M

    MDR report key: 17359638 · Received July 20, 2023

    Report

    Report Number
    9680841-2023-00029
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 21, 2023
    Report Date
    August 26, 2024
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE ITEM AND THE LOT OF THE CONVENIENCE PACK IS PENDING. THEREFORE ALSO THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS PENDING. INFORMATION WILL BE PROVIDED WHEN AVAIALABLE. G.5. THE INVOLVED INSPIRE 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050703) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K180448). H.4. THE ITEM AND THE LOT OF THE CONVENIENCE PACK IS PENDING. THEREFORE ALSO THE MANUFACTURE DATE IS PENDING. INFORMATION WILL BE PROVIDED WHEN AVAIALABLE. H.10. LIVANOVA MANUFACTURES THE INSPIRE 8M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN UNITED STATES. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    D.4. THE INSPIRE 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE ITEM AND THE LOT OF THE CONVENIENCE PACK ARE 044052501 AND 2314500059 RESPECTIVELY. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE LIVANOVA COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR CASE NOTIFIED FOR THE BATCH CONCERNED FROM THE MARKET, NEITHER CONCERNING TREND. NO VISUAL EVIDENCE OF THE EVENT WAS PROVIDED, CONSEQUENTLY UNIT WAS REQUESTED BACK FOR FUNCTIONAL TESTING AT LIVANOVA FACILITY. AFTER DECONTAMINATION, OXYGENATOR WAS VISUALLY INSPECTED AND NO VISIBLE SIGN OF DAMAGE TO THE FIBER BUNDLE CAPILLARIES OF THE HE MODULE NOR POTTING ANOMALY WERE OBSERVED. A SUBSEQUENT FUNCTIONAL TEST WAS PERFORMED TO VERIFY THE INTEGRITY OF THE WATER COMPARTMENT . THE UNIT WAS SUBJECTED TO AIR LEAK TEST BY SETTING THE SAME PARAMETERS APPLIED DURING THE IN-PROCESS LEAK TEST WHICH IS PERFORMED ON 100% OF THE UNITS IN MANUFACTURING LINE. ACCORDING TO LABORATORY RESULTS, COMPLAINED UNIT DID NOT PASS THE LEAK TEST. THE BLOOD SIDE OF THE UNIT WAS THEN DYE LEAK-TESTED TO REPRODUCE THE COMMUNICATION BETWEEN BLOOD AND WATER COMPARTMENTS COMPLAINED BY CUSTOMER. PART WAS FILLED WITH METHYLENE BLUE AND GRADUALLY PRESSURIZED BY SEALING ALL THE OUTLET PORTS, IN LINE WITH THE MAXIMUM INTERNAL PRESSURE VALUE PERMITTED IN BLOOD PATH (1 BAR). WHEN THE INTERNAL CIRCUIT PRESSURE REACHED 0.3 BAR, BREAKTHROUGH OF DYE SOLUTION ACROSS THE INNER FIBERS OF THE HEAT EXCHANGER MODULE WAS REPRODUCED. INVESTIGATION FINDINGS CONFIRMED THE PRESENCE OF AN OPEN CHANNEL BETWEEN BLOOD AND WATER COMPARTMENTS DUE TO DAMAGED CAPILLARY IN THE PROXIMAL PORTION OF HE FIBERS. CONSIDERING THAT 100% OF THE UNITS IN PRODUCTION LINE IS SUBJECTED TO FINAL AIR LEAK TEST AND THAT INVOLVED UNIT SUCCESSFULLY PASSED THE IN-PROCESS CHECK WITHOUT ANY DEVIATION AND NO TREND HAS BEEN REGISTERED FOR SIMILAR CASE, IT CANNOT BE EXCLUDED THAT FIBER BUNDLE CAPILLARY MANUFACTURING VARIABILITY WITH THE CONTRIBUTION OF THERMAL AND/OR TRANSPORTATION MECHANICAL STRESS COULD HAVE LED TO BREAKAGE DURING USE. NO SPECIFIC ACTION IS CURRENTLY DEEMED AS NECESSARY. LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. NO OTHER ACTION IS DEEMED NECESSARY. THE RISK IS IN THE ACCEPTABLE REGION. LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, BLOOD WAS SEEN IN THE OXY/HEATER COOLER CONNECTION AREA. HEATER COOLER WAS UNHOOKED AND BLOOD WAS NOTICED LEAKING FOR INPUT AND OUTPUT WATER CONNECTIONS OF THE OXY FOR HEATER COOLER. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105197 INSPIRE 8F M OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 03705 2302200078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown