BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LILLIPUT 1 OXYGENATOR

    MDR report key: 21025173 · Received December 27, 2024

    Report

    Report Number
    9680841-2024-00036
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    November 11, 2024
    Report Date
    March 13, 2025
    Manufacturer
    SORIN GROUP ITALY
    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

    D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 8 START P OXYGENATOR (CATALOG NUMBER: 050596) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. G.5. THE PRODUCT ITEM: 050596 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE LILLIPUT 1 HOLLOW FIBER OXYGENATOR 05318, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K953835). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. H11: SORIN GROUP ITALY MANUFACTURES THE LILLIPUT 1 OXYGENATOR. THE INCIDENT OCCURRED IN KOTA, INDIA. 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

    THROUGH FOLLOW UP, LIVANOVA LEARNED THAT THE DECREASED OXYGENATION LEVELS WERE DETECTED OUT OF THE AORTIC CROSS-CLAMP AFTER 3 HOURS OF BYPASS TIME, AND LASTED ABOUT 5 MINUTES. WHEN THE ARTERIAL PO2 VALUE WAS FOUND LOW (46 MMHG) A 1:1 GAS/BLOOD FLOW RATIO WAS IN USE (0,6 LPM). THE GAS BLENDER AND GAS LINE CONNECTIONS WERE CHECKED AND NO ANOMALY WAS IDENTIFIED. HOWEVER, NO TROUBLESHOOTING ACTIVITY WAS PUT IN PLACE: MEDICAL TEAM STARTED TO WEAN OFF THE PATIENT FROM CARDIOPULMONARY BYPASS AND DID NOT CHANGE OUT THE OXYGENATOR. THE SURGERY WAS UNEVENTFUL FOR THE PATIENT. REVIEW OF THE LIVANOVA COMPLAINTS DATABASE SHOWED NO OTHER SIMILAR INCIDENTS NOTIFIED FOR THE BATCH CONCERNED FROM THE MARKET. CONSIDERING THAT THE DECAY OF THE OXYGEN SATURATION LEVELS WAS TEMPORARY AND OCCURRED IN THE FINAL SURGICAL PHASE, IT IS REASONABLE TO CONCLUDE THAT THE MOST LIKELY ROOT CAUSE OF THE GAS EXCHANGE PERFORMANCE ISSUE WAS A SUDDEN ACTIVATION OF THE BLOOD CLOTTING PHENOMENON ALONG OXYGENATOR FIBERS DUE TO REDUCED AMOUNTS OF ANTICOAGULANT. NO SPECIFIC ACTION IS CURRENTLY DEEMED NECESSARY. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET. BASED ON THE INFORMATION THE DECREASED OXYGENATION LEVELS WERE DETECTED OUT OF THE AORTIC CROSS-CLAMP, THE EVENT HAS BEEN REASSESSED AS NOT REPORTABLE.

    Description of Event or Problem · 0

    SORIN GROUP ITALY RECEIVED A REPORT RELATED TO A LILLIPUT OXYGENATOR. THE USER SAW NO COLOR DIFFERENCE BETWEEN VENOUS AND ARTERIAL LINE: AT THAT TIME THE DEOXYGENATION WAS FIO2 100%, BUT PO2 IN ARTERIAL BLOOD GAS (ABG) WAS 46 MMHG. PATIENT SATURATION WAS BELOW 80. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965971 LILLIPUT 1 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALY 050596 2404260009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown