BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17387115 · Received July 25, 2023

    Report

    Report Number
    9611109-2023-00348
    Event Type
    Death
    Date Received
    July 25, 2023
    Date of Event
    January 7, 2014
    Report Date
    May 2, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THE HOSPITAL WHERE THE SURGERY TOOK PLACE. HOSPITAL NAME AND ADDRESS HAVE BEEN ADDED TO THE DEDICATED E SECTION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOWUP, LIVANOVA WAS INFORMED: SURGERY DATE: (B)(6) 2014. EVENT OUTCOME: DEATH. LEGAL LAWSUIT HAS BEEN ISSUED AND NO OTHER INFORMATION HAS BEEN MADE AVAILABLE OTHER THAN THAT REPORTED IN THE COMPLAINT FILE AND ATTACHED IN ADDITIONAL INFORMATION SECTION. A DHR REVIEW COULD NOT BE PERFORMED SINCE POSSIBLE SERIAL NUMBER INVOLVED WAS NOT PROVIDED. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND THE LIVANOVA DEVICE INVOLVEMENT AS WELL. LIVANOVA ALREADY IMPLEMENTED A STRATEGY TO DECREASE THE PROBABILITY OF BACTERIA GROW IN THE HC DEVICE BY APPLYING MULTIPLE MEASURES IMPLEMENTED OVER THE PAST FEW YEARS THROUGH DEDICATED CAPA AND FIELD ACTION. INVOLVED DEVICE SERIAL NUMBER REMAINED UNKNOWN BUT WAS NOT EQUIPPED WITH VACUUM AND SEALING KIT SINCE UPGRADE ACTIVITY STARTED IN 2017. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). H.9. LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Description of Event or Problem · 0

    THE EVENT WAS IDENTIFIED THROUGH A RETROSPECTIVE REVIEW OF PRODUCT LIABILITY LAWSUITS. THROUGH THIS REVIEW, WE HAVE IDENTIFIED A FEW EVENTS WHERE THE PLAINTIFF HAD FILED A SUIT AGAINST THE COMPANY, AND IT WAS HANDLED BY OUR LEGAL DEPARTMENT, BUT THE UNDERLYING PRODUCT INFORMATION HAD NOT BEEN FORWARDED TO THE COMPLAINT HANDLING UNIT. LIVANOVA OPENED A CAPA TO IDENTIFY ANY POSSIBLE LAWSUITS THAT MIGHT REQUIRE COMPLAINT REPORTING AND TO RETROSPECTIVELY SUBMIT THOSE EVENTS THAT WERE NOT PREVIOUSLY SUBMITTED AND TO PREVENT FUTURE SIMILAR ISSUES FROM OCCURRING. COMPLAINANT ALLEGES THROUGH THEIR COUNSEL THAT SHE UNDERWENT AN OPERATION BETWEEN (B)(6) 2014 AND (B)(6) 2014. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992715 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death| O