BEUDAMED
    FDA Adverse Event Death Summary report: N

    STOCKERT HEATER COOLER SYSTEM 3T

    MDR report key: 6043432 · Received October 20, 2016

    Report

    Report Number
    6043432
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 23, 2016
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LAST YEAR, A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT PROCEDURE X(4), AORTIC VALVE REPLACEMENT, AND ABDOMINAL AORTIC ANEURYSM REPAIR. PATIENT DID WELL WITH SURGERY, AND POST-OPERATIVELY. HOSPITAL RECEIVED NOTIFICATION, FROM ANOTHER STATE'S DEPARTMENT OF HEALTH, THAT THIS PATIENT HAD BEEN DIAGNOSED WITH MYCOBACTERIUM CHIMEREA INFECTION. THIS INFECTION HAS BEEN LINKED AT OTHER HOSPITALS TO THE HEATER COOLER DEVICE USED DURING THE PATIENT'S 2015 CARDIAC SURGERY. PATIENT EXPIRED IN FALL 2016.

    Description of Event or Problem · 1

    LAST YEAR, A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT PROCEDURE X(4), AORTIC VALVE REPLACEMENT, AND ABDOMINAL AORTIC ANEURYSM REPAIR. PATIENT DID WELL WITH SURGERY, AND POST-OPERATIVELY. HOSPITAL RECEIVED NOTIFICATION, FROM ANOTHER STATE'S DEPARTMENT OF HEALTH, THAT THIS PATIENT HAD BEEN DIAGNOSED WITH MYCOBACTERIUM CHIMEREA INFECTION. THIS INFECTION HAS BEEN LINKED AT OTHER HOSPITALS TO THE HEATER COOLER DEVICE USED DURING THE PATIENT'S 2015 CARDIAC SURGERY. PATIENT EXPIRED IN (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695737 STOCKERT HEATER COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP USA, INC. 16-02-85U

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death OTHER