BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINCINNATI SUB-ZERO

    MDR report key: 215356 · Received March 17, 1999

    Report

    Report Number
    MW1015964
    Event Type
    Injury
    Date Received
    March 17, 1999
    Date of Event
    February 21, 1999
    Report Date
    March 10, 1999
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM MFR. ON 4/13/1999: THE ECMO HEATER IS USED TO HEAT WATER. IT PROVIDES ONLY TEMPERATURE-CONTROLLED WARM WATER TO A BLOOD HEAT EXCHANGER. AT NO TIME DOES BLOOD ENTER INTO THE ECMO HEATER UNIT. IT IS THERFORE, TOTALLY IMPOSSIBLE THAT "BLOOD CLOT FOUND IN ECMO LINE" IS ACCURATE. THE EVENT STATEMENT THAT, "SHORTLY AFTER FILTER CHANGED, PATIENT BP AND OXYGEN SATURATION DECREASED" IS IRRELEVANT TO ECMO HEATER. THE ECMO HEATER DOES NOT HAVE A FILTER. IT IS THE CO'S OPINION THAT A LIFE-THREATENING EVENT REQUIRING INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE DID NOT OCCUR WITH REGARD TO THE CINCINNATI SUB-ZERO PRODUCT'S ECMO HEATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CINCINNATI SUB-ZERO ECMO DTZ CINCINNATI SUB-ZERO PRODUCTS, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Life Threatening| R