BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERCHART

    MDR report key: 3729625 · Received April 2, 2014

    Report

    Report Number
    3729625
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    December 6, 2013
    Report Date
    March 4, 2014
    Manufacturer
    CERNER CORPORATION
    Product Code
    OUG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDICATION ERROR. THIS EVENT WAS RELATED TO HEALTH INFORMATION TECHNOLOGY. SPECIFICALLY, THE MANNER IN WHICH THE SYSTEM PROCESSED AN ORDER FOR FREE WATER REPLACEMENT. ORDER WAS INTENDED TO BE 20ML/HR FOR 6 HOURS FOR A TOTAL OF 120ML. IT WAS A 1000 ML BAG SO FIRST THEY PUT 20ML/HR WHICH WOULD HAVE DEFAULTED THE INFUSE OVER TIME TO 50 HRS. THEY TRIED TO CHANGE THE INFUSE OVER TO 6 HOURS WHICH THEN CHANGES THE ML/HR RATE TO 167 ML/HR. THEY DID NOT NOTICE THIS HAD CHANGED. THEY DID NOT REALIZE THAT THEY NEEDED TO GO INTO DETAILS TAB TO SHOW THE TIME FRAME SO THE PATIENT GOT 167ML/HR INSTEAD OF 20ML/HR FOR 6 HOURS. ORDER WAS VERIFIED BY PHARMACY AND ADMINISTERED AT THAT RATE VIA PERIPHERAL IV. AFTER APPROXIMATELY 1L OF FLUID HAD INFUSED, PATIENT SHOWED SEIZURE ACTIVITY. PICU TEAM CALLED TO BEDSIDE. TREATMENT PROVIDED FOR SEIZURES AND CRITICAL SODIUM AND POTASSIUM.THE CERNER POWERCHART SOFTWARE SYSTEM HAS FUNCTIONALITY FOR CONTINUOUS MEDICATIONS/FLUID ORDERING THAT DOES NOT PREVENT "USER ERROR." WHEN THE PROVIDER ORDERS THE FLUID, EXAMPLE IS D5W, THE SCREEN OPENS TO A "CONTINUOUS DETAILS" ORDERING WINDOW. WITHIN THE SCREEN, THE ORDERING PROVIDER IS PRESENTED WITH A PRESELECTED BAG VOLUME AND TYPE OF FLUID WITH A BROWNISH BACKGROUND. THEY HAVE THE ABILITY TO MODIFY BAG VOLUME BUT IT WAS MADE THIS COLOR TO DISCOURAGE THAT CHANGE BY CERNER. THE RATE AND "INFUSE OVER" FIELDS ARE A YELLOW COLOR TO SHOW THAT THEY NEED TO BE COMPLETED. THE INTENT IS FOR AN ONGOING CONTINUOUS FLUID AND NOT TO LIMIT THE TIME. PROVIDERS CAN MISINTERPRET THIS FIELD TO MEAN THE LENGTH OF TIME THEY WANT THE ORDER TO INFUSE OVER, WHEN THE SYSTEM INTENT FOR THAT FIELD IS TO BE THE SYSTEM-CALCULATED LENGTH OF TIME UNTIL THE NEXT BAG SUPPLY WILL NEED TO BE SENT TO MAINTAIN THE CONTINUOUS INFUSION. THE COMPLETED FIELDS TURN WHITE. CERNER DOES NOT HAVE AN INTERMITTENT FLUID ADMINISTRATION ORDER SO PROVIDERS ARE EXPECTED TO GO TO A SECOND TAB, THE "DETAILS" TAB, WHERE THEY HAVE THE OPTIONS FOR IDENTIFYING THE DURATION OF THE INFUSION IN TERMS OF DOSES OR TIME. IF THE PROVIDER DOES NOT HAVE AWARENESS OF THIS INTENT AND MODIFIES THE "INFUSE OVER" FIELD FROM THE "CONTINUOUS DETAILS" TAB, THEY MAY INADVERTENTLY ORDER A HIGHER RATE THAN INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198993 POWERCHART MEDICAL DEVICE DATA SYSTEM OUG CERNER CORPORATION MILLENIUM ¿ VERSION 2010.19 *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other| R ALARIS PUMP