BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORIN - LIVANOVA

    MDR report key: 6563328 · Received May 11, 2017

    Report

    Report Number
    6563328
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    April 18, 2017
    Report Date
    May 1, 2017
    Manufacturer
    SORIN
    Product Code
    DWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH A HISTORY OF IDIOPATHIC CARDIOMYOPATHY S/P HEART TRANSPLANT (B)(6) 2012 WITH FAILURE TO THRIVE AND WEIGHT LOSS. FOUND TO HAVE RUL THREE IN BUD NODULES AND AFB CULTURE POSITIVE MYCOBACTERIUM CHIMAERA (B)(6) 2017. WE ARE EVALUATING IF THIS IS RELATED TO THE KNOWN ISSUE WITH HEATER COOLER DEVICES. PT STARTED ON THERAPY WITH AZITHROMYCIN, ETHAMBUTOL AND RIFABUTIN (B)(6) 2017. THE ISOLATE HAS BEEN SENT TO (B)(6) FOR WHOLE GENOME SEQUENCING TO SEE IF RELATED TO THE KNOWN MYCOBACTERIUM CHIMAERA INFECTIONS ASSOCIATED WITH (B)(4) STOCKERT 3T HEATER-COOLER SYSTEMS AS OUTLINE IN FDA SAFETY COMMUNICATIONS. WE EXPECT RESULTS IN SEVERAL WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340839 SORIN - LIVANOVA HEATER-COOLER DWC SORIN 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening HEART-LUNG MACHINE (B)(4)