BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT HEATER COOLER SYSTEM 3T

    MDR report key: 6085055 · Received November 8, 2016

    Report

    Report Number
    6085055
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    LIVANOVA SORIN GROUP USA INC.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN FDA ALERT WAS SENT OUT ON THE SORIN HEATING/COOLING MACHINE AND ITS ASSOCIATION WITH THE NONTUBERCULOUS MYCOBACTERIUM (NTM) INFECTION OF PATIENTS. THIS HOSPITAL HAS 3 OF THESE DEVICES, WHICH WERE PURCHASED APPROXIMATELY 4 YEARS AGO AND REMOVED FROM SERVICE (PER FDA RECOMMENDATIONS) ABOUT A MONTH AGO. AT THIS TIME, THIS HOSPITAL IS NOT AWARE OF ANY NTM INFECTIONS THAT HAVE OCCURRED IN OUR PATIENTS AS A RESULT OF THE USE OF THESE DEVICES. HOWEVER, DURING THE TIME PERIOD THESE DEVICES WERE USED, THERE WAS A POSSIBLE EXPOSURE TO APPROXIMATELY 1200 PATIENTS. THE HEATING/COOLING DEVICES AT THIS HOSPITAL HAVE NOT BEEN TESTED FOR NTM PER THE FDA RECOMMENDATIONS (LAST MONTH). PATIENTS THAT HAD SURGERY WHERE THIS DEVICE WAS BEING USED WILL BE INFORMED OF THE POTENTIAL EXPOSURE USING THE FDA SAMPLE LETTER AS A TEMPLATE. THESE DEVICES ARE NOT BEING REPORTED TO THE FDA AS A REQUIRED REPORT AS A RESULT OF INFECTION, BUT RATHER AS A VOLUNTARY REPORT FOR THE POTENTIAL OF INFECTION/INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737668 STOCKERT HEATER COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA SORIN GROUP USA INC. 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1