BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPS PLUS TABLE LINES

    MDR report key: 1642113 · Received February 9, 2010

    Report

    Report Number
    1642113
    Event Type
    Malfunction
    Date Received
    February 9, 2010
    Date of Event
    January 21, 2010
    Report Date
    February 9, 2010
    Manufacturer
    GISH BIOMEDICAL, INC.
    Product Code
    DTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC SURGERY, SUBSEQUENT TO THE AORTA BEING CLAMPED, AN ATTEMPT TO DELIVER COLD CARDIOPLEGIA SOLUTION TO THE HEART WAS MADE. ATTEMPT FAILED DUE TO A MALFUNCTION OF THE DELIVERY DEVICE. THE HEART WAS ISCHEMIC FOR APPROXIMATELY 60 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPS PLUS TABLE LINES TUBING, CARDIOPLEGIA, RESERVOIR DTR GISH BIOMEDICAL, INC. CPSTL8 160911B

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR CARDIAC DRUGS