BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3T

    MDR report key: 6545776 · Received May 4, 2017

    Report

    Report Number
    6545776
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    March 29, 2017
    Report Date
    April 16, 2017
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HOSPITALS WERE NOTIFIED THAT THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) INVESTIGATED SEVERAL CLUSTERS OF INFECTIONS THAT WERE LINKED TO EXPOSURES TO LIVANOVA (B)(4) (FORMERLY SORIN GROUP (B)(4)) STÖCKERT 3T HEATER-COOLER DEVICES OFTEN USED DURING CARDIAC SURGERY REQUIRING THE USE OF A HEART/LUNG MACHINE. THERE WERE NO REPORTS OF INFECTION AMONG THE PATIENTS ON WHOM THE DEVICES WERE USED PREVIOUSLY AT THIS HOSPITAL. SHORTLY AFTER NOTIFICATION THIS HOSPITAL ORDERED NEW HEATER-COOLER DEVICES BUT IN THE INTERIM CULTURED THE CURRENT DEVICES. CULTURE RESULTS WERE POSITIVE FOR MYCOBACTERIUM CHIMAERA. PER CDC GUIDELINES, 'HOSPITALS THAT HAVE IDENTIFIED CONTAMINATED 3T HEATER-COOLER DEVICES OR PATIENT INFECTIONS ASSOCIATED WITH DEVICES SHOULD PROMPTLY ALERT THEIR LOCAL OR STATE HEALTH DEPARTMENT AND SUBMIT A REPORT TO FDA VIA MEDWATCH.' MANUFACTURER RESPONSE FOR HEATER-COOLER UNITS, HEATER-COOLER UNIT (PER SITE REPORTER): FDA AND CDC SAFETY ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324373 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 OTHER DEVICES IN USE BUT NOT KNOWN TO HAVE CAUSED