BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SORIN HEATER-COOLER SYSTEM

    MDR report key: 10828609 · Received November 12, 2020

    Report

    Report Number
    10828609
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    April 25, 2018
    Report Date
    November 3, 2020
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MIDDLE-AGED PATIENT WITH SIGNIFICANT PMH (PAST MEDICAL HISTORY) OF OBESITY, OSA (OBSTRUCTIVE SLEEP APNEA), BICUSPID AORTIC VALVE AND ASCENDING AORTIC ANEURYSM S/P AORTIC VALVE REPLACEMENT WITH ON-X VALVE AND ASCENDING AORTIC ANEURYSM REPLACEMENT. PATIENT HAD ANOTHER CARDIAC SURGERY ~3 MONTHS LATER. CULTURES WERE OBTAINED AT THAT TIME. A MONTH LATER, WE RECEIVED LAB RESULTS THAT INFORMED US THAT PATIENT HAD M. CHIMAERA IN HIS AORTIC ROOT. THE INFECTION MAY HAVE ORIGINATED FROM THE USE OF THE SORIN HEATER - COOLER UNIT IN HIS PREVIOUS CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297446 SORIN HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA Life Threatening