BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER COOLER 3T (230 VOLT)

    MDR report key: 18490853 · Received January 11, 2024

    Report

    Report Number
    9611109-2024-00025
    Event Type
    Death
    Date Received
    January 11, 2024
    Date of Event
    March 4, 2016
    Report Date
    May 6, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW-UP COMMUNICATION WITH CUSTOMER, IT WAS LEARNED THAT POSSIBLE DEVICE SERIAL NUMBERS INVOLVED DURING THE SURGERIES WERE (B)(6) (MODEL 16-02-80). FOR BOTH DEVICE SERIAL NUMBERS, DEVICE HISTORY RECORD (DHR) REVIEW IS UNHELPFUL SINCE THEY WERE MANUFACTURED IN 2001 AND 2004 RESPECTIVELY, WHILE ALLEGED SURGERY ISSUE OCCURRED IN 2016 AND CONTRIBUTION OF POSSIBLE NATIVE DEFECTS CAN BE EXPECTED DURING FIRST USAGES. NO DEVICE BETWEEN THE ONES POSSIBLE INVOLVED AND IN USE AT THE HOSPITAL AT THE TIME OF SURGERY (2016) WAS EQUIPPED WITH VACUUM AND SEALING KIT. NO FURTHER INVESTIGATION IS POSSIBLE. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND A DIRECT RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND THE DEVICE COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    D.4. THE SERIAL NUMBER ARE UNKNOWN. THEREFORE UDI IS UNKNOWN. 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.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. 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 ITALY. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE SUBMISSION OF THIS REPORT WAS PLANNED FOR NOVEMBER 29, 2023; HOWEVER, DUE TO A NETWORK DISRUPTION AT LIVANOVA, THE ABILITY TO SUBMIT MDRS WAS LOST ON NOVEMBER 19, 2023, BEFORE THIS REPORT WAS READY TO SUBMIT. THE REPORT WAS PREPARED AND SUBMITTED FOLLOWING RESTORATION OF THE LIVANOVA SYSTEMS.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED, THROUGH A LAWSUIT, A REPORT THAT A MALE PATIENT UNDERGONE SURGERY ON (B)(6) 2016 WAS FOUND INFECTED BY MYCOBACTERIUM CHIMAERA AND DIED ON (B)(6) 2020. HEATER-COOLER SYSTEM 3T WAS USED DURING SURGERY. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS NOT CONFIRMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667916 HEATER COOLER 3T (230 VOLT) CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death