BEUDAMED
    FDA Adverse Event Death Summary report: N

    SORIN 3T HEATER-COOLER

    MDR report key: 7421468 · Received April 4, 2018

    Report

    Report Number
    7421468
    Event Type
    Death
    Date Received
    April 4, 2018
    Date of Event
    August 16, 2016
    Report Date
    April 3, 2018
    Manufacturer
    LIVANOVA PLC
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, PT UNDERWENT AN AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFT PROCEDURE FOR SEVERE AORTIC STENOSIS. ON 10/13/2016, CDC PUBLISHED A HEALTH ADVISORY: CDC ADVISES HOSPITALS TO ALERT PTS AT RISK FROM CONTAMINATED HEATER-COOLER DEVICES DURING CARDIAC SURGERY. AT THE TIME OF THE CDC EVALUATION WE HAD 4 HEATER-COOLER UNITS, ONE OF WHICH (#3), WAS THOUGHT TO BE AT GREATEST RISK DUE TO THE DATE OF MANUFACTURE. THE PT DIAGNOSED WITH M. CHIMAERA INFECTION WAS OPERATED ON (B)(6) OF 2016 WITH USE OF MACHINE #3. LATE IN THE FALL OF 2017, THE PT DEVELOPED FAILURE-TO-THRIVE, HYPOGLYCEMIA AND EXPERIENCED FALLS. WORK UP INCLUDED A BONE MARROW BIOPSY PERFORMED ON (B)(6) 2017 DUE TO PROGRESSIVE PANCYTOPENIA AND PRESUMED DIAGNOSIS OF MYELODYSPLASTIC SYNDROME. PT HAD CHRONIC ANEMIA DUE TO ESRD AND HAD LEUKOPENIA OBSERVED PRIOR TO HIS AORTIC VALVE REPLACEMENT. UNFORTUNATELY, HE EXPERIENCED PROGRESSIVE DETERIORATION AND OPTED FOR PALLIATIVE CARE. HIS BONE MARROW STUDY REVEALED NON-NECROTIZING GRANULOMA ON (B)(6) 2017 AND HE DIED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237702 SORIN 3T HEATER-COOLER 3T DWC LIVANOVA PLC SYSTEM 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death