BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F M

    MDR report key: 17078908 · Received June 7, 2023

    Report

    Report Number
    9680841-2023-00022
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 8, 2023
    Report Date
    August 28, 2023
    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

    D.4. THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK 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 8F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050703) IS 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. LIVANOVA MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN GERMANY. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. ACCORDING TO ADDITIONAL INFORMATION PROVIDED BY PERFUSIONIST, THE CHANGE OCCURRED IN THE PERIOD BETWEEN PROTOCOL 1 AND PROTOCOL 2. IT WAS ABOUT 5 MINUTES AFTER THE CARDIOPLEGIA ADMINISTRATION. DESPITE REQUESTED, CHANGE-OUT DURATION AND PHASE WAS NOT CLARIFIED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    VERIFICATION OF MANUFACTURING RECORDS CONFIRMED THAT NOTICED DEVICE WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. ANALYSIS OF COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR EVENT NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. VISUAL INSPECTION OF THE RETURNED OXYGENATOR AFTER DECONTAMINATION BY GAMMA-RAYS (AS PER LIVANOVA PROCEDURE ON BLOOD CONTAMINATED GOODS) FOUND CLOTTED BLOOD IN THE IAF MODULE AND IN THE OXYGENATOR FIBRES BUNDLE. DESPITE AN EXTENSIVE CLEANING, BLOOD DEPOSITS COULD NOT BE FULLY WASHED OUT FROM THE UNIT. OXYGENATOR WAS SUBJECTED TO FUNCTIONAL PRESSURE DROP VERIFICATION TEST WITH BOVINE BLOOD AS PER DESIGN SPECIFICATIONS AND RELEVANT UNI ISO. LABORATORY RESULTS FOUND THE HYDRAULIC RESISTANCE TO BLOOD FLOW EXCEEDED THE ACCEPTABLE RANGE OF VALUES PRESCRIBED WITHIN PRODUCT SPECIFICATIONS. SUCH A BEHAVIOR WAS TRACED BACK TO THE CONDITIONS OF RETURNED OXYGENATOR. 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. 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 THE BEGINNING OF BYPASS DURING CARDIOPLEGIA DELIVERY, THE TRANSMEMBRANE PRESSURE IN THE INSPIRE 8F OXYGENATOR INCREASED . THERE IS NO REPORT OF ANY PATIENT INJURY. MEDICAL TEAM ELECTED TO CHANGE-OUT OF THE MACHINE AND DISPOSABLE CIRCUIT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587093 INSPIRE 8F M OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 03705PTS 2303240098

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown