BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE STOCKERT HEATER-COOLER SYSTEM (3T)

    MDR report key: 6113154 · Received November 17, 2016

    Report

    Report Number
    MW5066126
    Event Type
    Death
    Date Received
    November 17, 2016
    Date of Event
    April 17, 2015
    Report Date
    November 17, 2016
    Manufacturer
    SORIN GROUP
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPRESENTED TO OUR FACILITY WITH WHAT WAS LATER IDENTIFIED AS NON-TUBERCULOSIS MYCOBACTERIUM INFECTION AFTER CARDIAC BYPASS SURGERY A YEAR PRIOR (ORIGINAL SURGERY AT (B)(6) HOSPITAL). HE DIED FROM COMPLICATIONS OF THE INFECTION. THE EXPOSURE DID NOT OCCUR AT OUR FACILITY. WE ARE REFERRING THE CASE GIVEN THE SUSPICION THAT IT FITS WITH KNOWN SIMILAR CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759439 THE STOCKERT HEATER-COOLER SYSTEM (3T) THE STOCKERT HEATER-COOLER SYSTEM (3T) DWC SORIN GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| L