BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVA NOVA 3T HEATER/COOLER HCD

    MDR report key: 7002738 · Received November 6, 2017

    Report

    Report Number
    MW5073126
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    August 19, 2017
    Report Date
    November 2, 2017
    Manufacturer
    STOCKERT SORIN
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    CABG AND VALVE REPLACEMENT SURGERY PERFORMED. DURING PROCEDURE, STOCKERT LIVANOVA 3T HCD (HEATER/COOLER DEVICE) WAS USED. PLACEMENT, CLEANING, AND USE OF THE MACHINE WAS FOLLOWED PER CDC GUIDELINES. SPECIMEN CULTURES OBTAINED DURING THE PROCEDURE RETURNED POSITIVE FOR M. CHIMAERA BACTERIUM. THE PT HAS TESTED NEGATIVE FOR M. CHIMAERA BACTERIUM. THE CONCERN IS THAT CONTAMINATED AIR MAY HAVE BEEN BLOWN ONTO THE PT AND/OR SURGICAL FIELD DESPITE FOLLOWING RECOMMENDED PLACEMENT OF THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783982 LIVA NOVA 3T HEATER/COOLER HCD CONTROLLER TEMPERATURE DWC STOCKERT SORIN MCG-1000(I)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other