BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROSS

    MDR report key: 385028 · Received March 27, 2002

    Report

    Report Number
    MW1024491
    Event Type
    Death
    Date Received
    March 27, 2002
    Date of Event
    November 1, 2000
    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 TURNED BLUE TO FACE AND NECK, BLUE-GREEN TO TRUNK AND DUSKY BLUE TO DISTAL EXTREMITIES AFTER RECEIVING TUBE FEEDING FORMULA VIA COLORMARK TUBING. PT HAD A MITRAL VALVE REPLACEMENT, RENAL FAILURE-HEMODIALYSIS, RESPIRATORY FAILURE. THE PT WAS NOT TAKING ANY DRUGS KNOWN TO CAUSE DISCOLORATION. PT WAS RECEIVING NEPRO AT 40 CC/HR FROM 10/19/00 - 10/31/00 VIA NGT. PT WAS ON A VENTILATOR UNTIL TIME OF DEATH. PT WAS MADE "DO NOT RESUSCITATE" ON 10/31/00. PRESSORS WERE STOPPED ON 11/1/00. BP DROPPED AND BECAME ASYSTOLIC. PT TURNED BLUE. PT HAD MULTISYSTEM FAILURE, AND STAPH. NO AUTOPSY COMPLETED, NO PICTURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death