BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 18884373 · Received March 12, 2024

    Report

    Report Number
    9680841-2024-00006
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 10, 2024
    Report Date
    June 25, 2024
    Manufacturer
    SORIN GROUP ITALIA SRL.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. D.4. THE INSPIRE 7F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN01850, LOT 2310270098) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED INSPIRE 7F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050729) IS REGISTERED IN THE USA (510(K) NUMBER: K200683). 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 INSPIRE 7F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN BAD NEUSTADT/SAALE, GERMANY. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF LIVANOVA COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR EVENT NOTIFIED FOR THE BATCH CONCERNED FROM THE MARKET PUMP SHEET OF THE CASE WAS PROVIDED AND ANALYZED, CONFIRMING THE GRADUAL RISING OF THE PRESSURE IN FRONT OF THE DEVICE IN THE INITIAL PHASE OF THE CASE. THE LAST BLOOD-GAS DATA REPORT WITH THE COMPLAINED DEVICE BEFORE THE CHANGE-OUT WAS TAKEN AT 11:43, WHILE THE FIRST ONE WITH THE NEW UNIT INSTALLED WAS TAKEN AT 12:05. THE CHANGE-OUT OF THE MACHINE WAS COMPLETED IN 2 MINUTES. AFTER DECONTAMINATION BY GAMMA-RAYS (AS PER LIVANOVA PROCEDURE ON BLOOD CONTAMINATED GOODS), RETURNED UNIT WAS VISUALLY INSPECTED AND PRESENCE OF DRIED BLOOD ALONG OXYGENATOR FIBRES WAS NOTICED. A CLEANING OPERATION WAS CARRIED OUT TO PURGE THE DEVICE FROM OBSERVED BIOLOGICAL TRACES. IN DETAIL, BLOOD COMPARTMENT WAS FIRST FLUSHED WITH DEMINERALIZED WATER AND THEN DRIED WITH COMPRESSED AIR: DURING THIS STEP BIOLOGICAL FLUID WAS EJECTED FROM ALL THE OUTLET PORTS OF THE UNIT. UPON COMPLETION OF CLEANING PHASE, THE OXYGENATOR WAS SUBJECTED TO FUNCTIONAL PRESSURE DROP VERIFICATION TEST WITH BOVINE BLOOD AS PER DESIGN SPECIFICATIONS AND RELEVANT UNI ISO. LABORATORY TEST COULD NOT REPRODUCE ANY INCREASED PRESSURE DROP ACROSS THE OXYGENATOR WHICH BEHAVED AS EXPECTED WITHOUT ANY PERFORMANCE DEVIATION IDENTIFIED IN TERMS OF PRESSURE EXCURSION IN BLOOD PATH. MEASURED ¿P IN BLOOD PATH WAS FOUND ALIGNED WITH ACCEPTABLE RANGE OF VALUES PRESCRIBED WITHIN PRODUCT SPECIFICATIONS AS PER REPORTED BLOOD PARAMETERS TEST CONDITIONS. RETURNED DEVICE DID NOT EXHIBIT ANY INCREASED HYDRAULIC RESISTANCE DURING THE TEST: FIBERS WERE FOUND PATENT AND NOT OCCLUDED. NO MANUFACTURING QUALITY ISSUE POSSIBLY LINKED WITH THE REPORTED CONDITION WAS CONFIRMED ACCORDINGLY. TAKING INTO ACCOUNT THE INVESTIGATION RESULTS, REPORTED EVENT WAS REASONABLY TRACED BACK TO UNEXPECTED AND PROGRESSIVE BUILD UP OF BIOLOGICAL DEPOSITS (PLATELET AGGREGATES AND FIBRIN MASS) INSIDE THE OXYGENATOR FIBERS WHICH REDUCED THE OPEN SURFACE FOR BLOOD FLOW. LIVANOVA CONDUCTED A LITERATURE AND TECHNICAL ANALYSIS ABOUT THE TRANS-MEMBRANE OXYGENATOR PRESSURE GRADIENTS. PRESSURE DROP EXCURSION ACROSS THE OXYGENATOR IS A KNOWN PHENOMENON REPORTED IN LITERATURE IN ALL MEMBRANE OXYGENATORS. THE MAIN CAUSE OF THE PRESSURE EXCURSION HAS BEEN IDENTIFIED IN THE PLATELET ACTIVATION AND ADHESION WITHIN THE OXYGENATOR THAT PROGRESSES TO INCREASE RESISTANCE TO BLOOD FLOW DURING CARDIOPULMONARY BYPASS. THE FACTORS INFLUENCING PRESSURE EXCURSIONS CAN BE ASSIGNED TO THREE MAIN AREAS: - SURGERY CLINICAL IMPACT - CPB CLINICAL IMPACT - PATHOLOGICAL PATIENT CONDITIONS RESEARCH ON THE PHENOMENON CONSISTENTLY CONCLUDES THAT THE PRESSURE EXCURSION IS COMPLEX AND MULTIFACTORIAL AND IN MOST OF THE CASES NONE OF THE FACTORS CONSIDERED SINGULARLY CAUSES THE PHENOMENON. AN ACCURATE ANALYSIS AND MONITORING OF THE FACTORS IDENTIFIED CAN LEAD TO THE REDUCTION OF THE PHENOMENON DURING CPB. NEVERTHELESS AT CURRENT STATE OF KNOWLEDGE THE COMPLEX NATURE OF THE PHENOMENON DOES NOT ALLOW ITS COMPLETE ELIMINATION. SINCE THE CHANGE-OUT OF THE MACHINE WAS COMPLETED IN 2 MINUTES, THE EVENT HAS BEEN REASSESSED AS NOT-REPORTABLE 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

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, AFTER 15 MINUTES FROM THE BEGINNING OF THE BYPASS PROCEDURE, THE TRANSMEMBRANE INSPIRE OXYGENATOR PRESSURE INCREASED REACHING THE PRESSURE LIMIT OF 600 MMHG. IN ADDITION ACT (ACTIVATED CLOTTING TIME) WAS ALWAYS OVER 500. MEDICAL TEAM ELECTED TO CHANGE-OUT THE ENTIRE HLM SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. DUE TO A QUICK MACHINE CHANGE, THE PATIENT WAS NOT HARMED.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910611 INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL. 03735 2311040003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown