BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 15474962 · Received September 23, 2022

    Report

    Report Number
    9680841-2022-00042
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 10, 2022
    Report Date
    October 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

    THE COMPLAINED INSPIRE 6F OXYGENATOR (CATALOG NUMBER 050715CN, LOT 2202050006) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050715CN IS SIMILAR TO THE INSPIRE 6F OXYGENATOR 050715, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(6). THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT CATALOG NUMBER 050715CN. THE INVOLVED OXYGENATOR IS NOT MADE AVAILABLE FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. THE COMPLAINED INSPIRE 6F OXYGENATOR 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). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR CATALOG NUMBER 050715CN. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F OXYGENATOR. THE INCIDENT OCCURRED IN(B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA HAS RECEIVED A REPORT THAT, AT THE BEGINNING OF A PROCEDURE THE PATIENT BLOOD WAS DARK AND THE PATIENT BLOOD OXYGEN SATURATION WAS 50%. MEDICAL TEAM VERIFIED THE INSTALLATION AND CONNECTION OF THE OXYGEN SUPPLY TUBE, THE EXTRACORPOREAL CIRCULATION MACHINE AND VARIOUS PIPELINES WERE CORRECT. AFTER 5 MINUTES FROM BEGINNING, THE BLOOD GAS ANALYSIS SHOWED AN ARTERIAL PO2 OF 35 MMHG. MEDICAL TEAM ELECTED TO STOP THE EXTRACORPOREAL CIRCULATION AND A VENTILATOR WAS USED TO SUPPLY OXYGEN. THE PATIENT'S BLOOD OXYGEN SATURATION AND BLOOD GAS ANALYSIS REPORTED RESULTS COMPARABLE TO THE ONES BEFORE INITIATE THE PROCEDURE. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. AFTER THE REPLACEMENT, THE MACHINE WAS SWITCHED ON AGAIN, THE PATIENT BLOOD APPEARED BRIGHT RED, PATIENT BLOOD OXYGEN SATURATION WAS 100%, THE BLOOD GAS ANALYSIS RESULT WAS AS EXPECTED, AND PROCEDURE WAS INITIATED AT 11:55. INTRAOPERATIVE BLOOD GAS ANALYSIS RESULTS WERE NORMAL. THERE IS NO REPORT OF ANY PATIENT INJURY. THE UNIT WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. HOWEVER, BLOOD GAS ANALYSIS HAS BEEN PERFORMED REVEALING THAT FIO2 WAS INCREASED FROM 50% TO 70%. AS PER INSPIRE 6F IFU REGARDING BLOOD GAS MONITORING, DEPENDING ON THE VALUES FOUND OF MEASURED BLOOD-GAS, THE RELEVANT PARAMETERS SHOULD BE ADJUSTED AS FOLLOWS: IN CASE OF HIGH PO2, FIO2 SHOULD BE DECREASED, WHILE IN CASE OF LOW PO2, FIO2 SHOULD BE INCREASED. IN ADDITION, THE SUGGESTED GAS/BLOOD FLOW RATIO IN NORMOTHERMIC CONDITIONS IS 1:1 WITH AN FIO2 OF 80 TO 100%. DHR REVIEW REVEALED THAT NO FURTHER SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR NOTICED PRODUCT LOT ON A TOTAL OF 288 MANUFACTURED UNITS WORLDWIDE DISTRIBUTED, THUS EXCLUDING ANY SYSTEMATIC QUALITY PROBLEM. THEREFORE, BASED ON ALL THE ABOVE FACTS, IT CANNOT BE EXCLUDED THAT THE MOST LIKELY ROOT CAUSE OF THIS TEMPORARY LOW OXYGENATION CONDITION WAS A MULTIFACTORIAL ISSUE, RESULTING FROM THE INTERACTION BETWEEN CLINICAL PROCEDURE, PATIENT CONDITIONS AND INITIAL GAS-BLOOD SETTINGS. NO OTHER 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, AT THE BEGINNING OF A PROCEDURE (10:54) PATIENT BLOOD WAS DARK AND THE PATIENT BLOOD OXYGEN SATURATION WAS 50%. MEDICAL TEAM VERIFIED THE INSTALLATION AND CONNECTION OF THE OXYGEN SUPPLY TUBE, THE EXTRACORPOREAL CIRCULATION MACHINE AND VARIOUS PIPELINES WERE CORRECT. AFTER 5 MINUTES (AT 10:59), THE BLOOD GAS ANALYSIS SHOWED AN ARTERIAL PO2 OF 35 MMHG. MEDICAL TEAM ELECTED TO STOP THE EXTRACORPOREAL CIRCULATION AND A VENTILATOR WAS USED TO SUPPLY OXYGEN. THE PATIENT'S BLOOD OXYGEN SATURATION AND BLOOD GAS ANALYSIS REPORTED RESULTS COMPARABLE TO THE ONES BEFORE INITIATE THE PROCEDURE. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. AFTER THE REPLACEMENT, THE MACHINE WAS SWITCHED ON AGAIN (AT 11:09), THE PATIENT BLOOD APPEARED BRIGHT RED, PATIENT BLOOD OXYGEN SATURATION WAS 100%, THE BLOOD GAS ANALYSIS RESULT WAS AS EXPECTED, AND PROCEDURE WAS INITIATED AT 11:55. INTRAOPERATIVE BLOOD GAS ANALYSIS RESULTS WERE NORMAL. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2828538 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2202050006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown