BEUDAMED
    FDA Adverse Event Death Summary report: N

    STOCKERT - SORIN 3T HEATER COOLER

    MDR report key: 3984530 · Received August 6, 2014

    Report

    Report Number
    3984530
    Event Type
    Death
    Date Received
    August 6, 2014
    Report Date
    August 1, 2014
    Manufacturer
    SORIN GROUP USA
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE 15 PTS HAVE TESTED POSITIVE +AFB FOR AN ATYPICAL MYCOBACTERIUM INFECTION. ALL INFECTIONS HAVE BEEN SURGICAL SITE INFECTIONS. THE INVESTIGATION IS STILL ON-GOING. THE COMMON DENOMINATOR FOR THE CARDIAC SURGERIES IS THE PROFUSION MACHINE. THE MACHINE HAS BEEN CULTURED AND FOUND TO HAVE THE MYCOBACTERIUM IN THE WATER. THE MACHINE WAS PULLED FROM SERVICE (B)(6) 2014. THE TERUMO HEALTH EXCHANGER WAS BEING USED ON THE MACHINE. (B)(6) HAS INCREASED THE FREQUENCY OF THE VENDOR'S RECOMMENDATION FOR DISINFECTION FROM EVERY TWO WEEKS TO WEEKLY. OUT OF THE 15 PTS THAT WERE INFECTED, 4 HAVE EXPIRED. THE INFECTIONS WERE THOUGHT TO BE A CONTRIBUTING FACTOR, YET ALL PTS HAD MAJOR, UNDERLYING EXISTING AND SIGNIFICANT MEDICAL CONDITIONS. SEVERAL PTS IN THE HOSP PRESENTED WITH POST-OPERATIVE WOUND INFECTIONS CAUSED BY AN UNUSUAL ORGANISM, ATYPICAL MYCOBACTERIUM. IT HAS BEEN DETERMINED THAT A TOTAL OF 15 PTS WHO HAD SURGERY WERE INFECTED. THE INVESTIGATION IS STILL ON-GOING AND THE EXACT ETIOLOGY IS STILL UNK. A COMMON FACTOR FOR MANY OF THE PTS INFECTED IS THE SORIN PROFUSION MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459579 STOCKERT - SORIN 3T HEATER COOLER 3T HEATER COOLER DWC SORIN GROUP USA 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death