BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROSS

    MDR report key: 385012 · Received March 27, 2002

    Report

    Report Number
    MW1024490
    Event Type
    Death
    Date Received
    March 27, 2002
    Date of Event
    June 4, 2001
    Report Date
    March 13, 2002
    Manufacturer
    ROSS PRODUCTS DIV. ABBOTT LABORATORIES, INC.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    DIETICIAN

    Narratives

    Description of Event or Problem · 1

    PT'S SKIN, URINE, AND STOOL TURNED BLUE AFTER RECEIVING BLUE DYE IN TUBE FEEDING FORMULA VIA COLOR MARK TUBING. PT WAS SEPTIC AT THE TIME WHICH MAY HAVE CONTRIBUTED TO SYSTEMIC ABSORPTION OF THE DYE. PT EXPIRED. NO AUTOPSY COMPLETED. THE TUBE FEEDING AND BLUE DYE WAS ADMINISTERED FOR A TOTAL OF 40 HRS AT 15-35 CC/HR. THE FEEDING WAS STOPPED SEVERAL TIMES SECONDARY TO HIGH RESIDUALS. PT WAS MADE A "DO NOT RESUSCITATE". BREATHING TREATMENTS WERE STOPPED (EXCEPT VENTILATOR). PT'S BLOOD PRESSURE DROPPED VERY LOW TO THE POINT THAT IT COULD NOT BE FOUND AND PT STOPPED BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS COLOR MARK TUBING (CONTAINS BLUE DYE TABLET) FPD ROSS PRODUCTS DIV. ABBOTT LABORATORIES, INC. 54550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death