BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3T HEATER COOLER

    MDR report key: 17841869 · Received September 29, 2023

    Report

    Report Number
    1718850-2023-01022
    Event Type
    Injury
    Date Received
    September 29, 2023
    Report Date
    August 31, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.2-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. THE CATALOGUE AND 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, BUT 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. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN UNITES STATES. 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

    THE COMPLAINANT ALLEGES THROUGH THEIR COUNSEL THAT POSITIVE AFB CULTURE FOR M. CHIMAERA (COLLECTED MAY 5, POSITIVE ON MAY 17). SURGERY WAS ON JUNE 2019. BASED ON THE CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316498 3T HEATER COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male