BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUNRISE CLINICAL MANAGER 5.5

    MDR report key: 2202130 · Received August 4, 2011

    Report

    Report Number
    MW5021673
    Event Type
    Death
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 4, 2011
    Product Code
    NSX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH FAILURE OF SEVERAL ORGANS WAS BECOMING DEHYDRATED. IT WAS DECIDED TO HYDRATE THE PT WITH 500 CC OF FLUID AT 60 CC PER HOUR. THE CPOE HAS AVAILABLE FOR SELECTION 500 CC AND 500 CC WAS SELECTED. HOWEVER, THE FLUID, RAN IN TO THE PT CONTINUOUSLY, RESULTING IN A FLUID OVERDOSE OF 3X IN EXCESS OF WHAT WAS ORIGINALLY ORDERED. THE PT DEVELOPED PULMONARY EDEMA OF THE LUNGS AND FURTHER COMPLICATIONS RESULTED IN DEATH. IN THIS CASE, THE ORDER ENTRY DEVICE HAS AMBIGUOUS AND MISLEADING INFORMATION THAT RESULTED IN THE FLUID OVERDOSE, AND THEN DEATH "DOR THIS INFORM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNRISE CLINICAL MANAGER 5.5 CPOE NSX

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death