BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOTHERM

    MDR report key: 1991176 · Received February 8, 2011

    Report

    Report Number
    1516825-2011-00005
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL EVALUATION OF THE COMPLAINT AND COMMUNICATIONS WITH THE COMPLAINANT CANNOT CONFIRM THAT THE DEVICE REFERENCED RESULTED IN OR CONTRIBUTED TO THE PATIENT'S DEATH. COMMUNICATION IS ONGOING WITH THE COMPLAINANT TO FURTHER INVESTIGATE THE FACTS. THE COMPLAINANT WAS IMMEDIATELY INSTRUCTED NOT TO USE THE DEVICE UNTIL A ROOT CAUSE ANALYSIS AND CORRECTION PLAN IS COMPLETE. A REQUEST HAS BEEN SUBMITTED FOR ADDITIONAL INFORMATION FROM THE HOSPITAL AND DEVICE DISTRIBUTOR TO PROPERLY DOCUMENT AND ASSESS THE COMPLAINT. CERTAIN ITEMS REQUIRED ON THIS FORM ARE NOT AVAILABLE UNTIL OUR REQUESTED INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE AREA SALES MANAGER REPORTED THAT AT (B)(6), THAT DURING A PROCEDURE (A CASE), THE HEMOTHERM (B)(4) MALFUNCTIONED. DURING THE MIDDLE OF THE CASE, THEY FOUND THAT THE DISPLAY OF THE HEATER SIDE SHOWS "EE" AND NO BUTTON WAS WORKING. THE CUSTOMER INFORMED THAT THE TEMPERATURE OF THE WATER GOES REALLY HIGH AND EVEN THEY WERE UNABLE TO PUT THEIR FINGER INSIDE THE WATER WHICH LOOKS UNUSUAL AND ACCORDING TO THEIR STATEMENT IT WAS MUCH MORE THAN 44 DEGREES (AROUND 100 DEGREES). THEY COULDN'T FIND ANYWAY TO REDUCE THE TEMPERATURE AND FINALLY THE PATIENT DIED BECAUSE OF OVERHEAT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOTHERM CARDIOPULMONARY BYPASS TEMP CONTROLLER DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 400MR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death