BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TCM II Y CIRCUIT

    MDR report key: 10377 · Received December 6, 1993

    Report

    Report Number
    MW1000016
    Event Type
    Malfunction
    Date Received
    December 6, 1993
    Date of Event
    September 16, 1993
    Report Date
    November 12, 1993
    Manufacturer
    SARNS 3M HEALTH CARE, INC.
    Product Code
    MJJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIOPULMONARY BYPASS, FOLLOWING REMOVAL OF THE AORTIC CLAMP, THE H20 TEMPERATURE OF THE SYSTEMIC HEATER/COOLER WAS ALLOWED TO COOL RATHER THAN WARM. THE WATER TEMPERATURE DROPPED FROM 40 DEGREES C TO 26 DEGREES C. THIS CAUSED A DRIP IN BLOOD TEMPERATURE FROM 36 DEGRESS C TO 28 DEGREES C. A DIFFERENT HEATER/COOLER WAS BROUGHT IN TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT ON PT. A COMBINATION OF VALVES AND TEES RECOMMENDED BY THE MFR MAY CONTRIBUTE TO OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TCM II Y CIRCUIT 1/2" 2-WAY BALL VALVE MJJ SARNS 3M HEALTH CARE, INC. 14191010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR