BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRO-TEMP PUMP

    MDR report key: 728968 · Received June 26, 2006

    Report

    Report Number
    728968
    Event Type
    Death
    Date Received
    June 26, 2006
    Date of Event
    June 5, 2006
    Report Date
    June 23, 2006
    Manufacturer
    CINCINNATI SUB ZERO PRODUCTS, INC.
    Product Code
    ILO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON INITIATION OF ECMO, HEATER #1 FAILED. EXCHANGED WITH HEATER #2. TEMPERATURE OF BABY DECREASED. HEATER #2 FAILED. EXCHANGED WITH HEATER #3. HEATER #3 WORKED APPROPRIATELY. TEMPERATURE RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-TEMP PUMP HEAT THERAPY SYSTEM ILO CINCINNATI SUB ZERO PRODUCTS, INC. MICRO-TEMP PUMP 70-6071-003-00
    2 MICRO TEMP SMS 2000 HEAT THERAPY SYSTEM DWJ SEABROOK MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY Death