BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 10188230 · Received June 24, 2020

    Report

    Report Number
    9680841-2020-00010
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    May 27, 2020
    Report Date
    June 26, 2020
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED INSPIRE OXYGENATOR 6F HAS BEEN RETURNED TO LIVANOVA FOR INVESTIGATION AND IT HAS BEEN SUBJECTED TO GAMMA-RAY DECONTAMINATION AS PER LIVANOVA PROCEDURE ON BLOOD CONTAMINATED GOODS. VISUAL INSPECTION OF THE RETURNED OXYGENATOR FOUND NO PROBLEM. TO INVESTIGATE THE REPORTED FAILURE (LOW OXYGENATION VALUES), THE DEVICE CAPACITY TO TRANSFER OXYGEN AND REMOVE CARBON DIOXIDE HAS BEEN TESTED AS PER RELEVANT ISO STANDARDS. O2 TRANSFER AND CO2 REMOVAL OF THE RETURNED OXYGENATOR WERE BELOW EXPECTED PERFORMANCE FOR A BRAND-NEW DEVICE. IT SHOULD BE NOTICED THAT RETURNED OXYGENATOR SHOULD BE CONSIDERED AN OVER STRESSED DEVICE DUE TO PREVIOUS CLINICAL USAGE, DECONTAMINATION TREATMENT, TRANSPORTATION AND STORAGE CONDITIONS WHICH IMPLY A CERTAIN LEVEL OF BIOLOGICAL DEPOSITION ON THE FIBER BUNDLE POSSIBLY OCCLUDING MICROPORES ON THE MEMBRANE. ACCORDINGLY, DURING THE PERFORMANCE TEST, WATER CONDENSATION INSIDE MICROPOROUS FIBERS WAS OBSERVED SUGGESTING A HIGH LEVEL OF HYDROPHILIZATION OF THE FIBERS OF THE RETURNED OXYGENATOR. THE HYDROPHILIZATION OF THE FIBERS IS MOST LIKELY ASCRIBABLE TO PLASMA-PROTEIN DEPOSITS IN THE OXYGENATOR AFFECTING THE OVERALL GAS EXCHANGE PERFORMANCE. THE CUSTOMER HAS ALSO RETURNED SOME RESULTS OF THE BLOOD GAS ANALYSIS PERFORMED BY THE CLINICAL TEAM DURING THE SURGERY. MATHEMATICAL ANALYSIS OF THE PROVIDED DATA SHOWED THAT O2 TRANSFER PERFORMANCES WERE ALIGNED TO CLINICAL MANEUVERS APPLIED DURING SURGERY. IN FACT, A PO2 PEAK VALUE OF 260 MMHG IN ARTERIAL LINE WAS REACHED AND A HEMOGLOBIN OXYGEN SATURATION (SAT O2) PERCENTAGE OF 99,8 % WAS ACHIEVED BY KEEPING CONSTANTLY THE FIO2 AT 100%. IFU'S OF THE PRODUCT RECOMMEND INCREASING THE FIO2 IN CASE LOW PO2 VALUES ARE MEASURED IN THIS REGARD. MANUFACTURING RECORDS AND COMPLAINT HISTORY WERE REVIEWED: CLAIMED DEVICE WAS RELEASED AS CONFORM TO SPECIFICATIONS AND NO FURTHER SIMILAR COMPLAINTS WERE RECORDED FOR NOTICED PRODUCT LOT. MOREOVER, NO FURTHER SIMILAR COMPLAINTS WERE RECORDED FOR NOTICED PRODUCT LOT CONFIRMING A NON-SYSTEMATIC EVENT. BASED ON ALL THE ABOVE, LIVANOVA BELIEVES THAT THE CONDITIONS OF RETURNED DEVICE DID NOT ALLOW TO ACHIEVE ANY SIGNIFICANT TEST RESULTS AND THEREFORE NO ROOT CAUSE COULD BE CLEARLY ASSESSED. LIVANOVA WILL MAINTAIN MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN00993, LOT 2003100075). THE STERILE CONVENIENCE PACK 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. THE COMPLAINED INSPIRE 6F 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 050702) IS REGISTERED IN THE USA (510(K) NUMBER: K180448). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION AND IT HAS NOT YET BEEN RETURNED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE PO2 VALUES WERE LOW. THE MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651527 INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL 2003100002

    Patients

    Seq Age Sex Outcome Treatment
    1