BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVANOVA 3T HCD

    MDR report key: 20201485 · Received September 11, 2024

    Report

    Report Number
    MW5159518
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    September 27, 2019
    Report Date
    September 9, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HCD LIVANOVA 3T M. CHIMAERA INFECTION AFTER LVAD PLACEMENT (B)(6) 2019. DISCOVERED (B)(6) 2024 BY ID. (B)(6) 2019 LVAD INSERTION (DESTINATION) COMPLICATED BY DRIVELINE EXIT SITE PAIN (B)(6) 2021 AND CULTURE-NEGATIVE, TREATED WITH EMPIRIC ANTIBACTERIALS WITHOUT SUCCESS AND DEVELOPED ADDITIONAL WOUNDS/SINUS TRACTS BY (B)(6) 2024. TRANSPLANT ID DID AFB CULTURES AT THAT TIME WHICH GREW MAIC UNFORTUNATELY LIKELY TO ID AS MYCOBACTERIUM CHIMAERA FROM (B)(6) 2024. MEETS CASE DEFINITION FOR THE HCD LIVANOVA 3T OUTBREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584554 LIVANOVA 3T HCD CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other