BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER MILLENNIUM POWERORDERS AND MED PROFILE

    MDR report key: 1051313 · Received May 23, 2008

    Report

    Report Number
    1931259-2008-00004
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    CERNER CORP.
    Product Code
    LNX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER HAS DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION MAY 23, 2008 TO ALL POTENTIALLY IMPACTED CLIENTS SITES. THE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND AN INTERIM WORKFLOW ADJUSTMENT TO PREVENT THE MALFUNCTION. USER DOCUMENTATION IS BEING UPDATED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE DOCUMENTATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE ISSUE INVOLVES THE ORDER ENTRY FORMATS IN POWERORDERS AND AFFECTS SITES THAT USE POWERORDERS AND MEDICATION PROFILE. WHEN CREATING THE VOLUME DOSE DETAIL IN THE ORDER ENTRY FORMATS (OEF), THE STRENGTH ORDER FORMATS REQUIRE THE VOLUME DOSE TO HAVE AN "=" SIGN AS A PREFIX LABEL. FAILURE TO ADHERE TO THIS BUILD CAN RESULT IN AN INPATIENT PRESCRIPTION ORDER CONVERTED TO PRODUCE AN OUTPATIENT PRESCRIPTION THAT MAY BE MISLEADING. THIS ONLY OCCURS WHEN THE INPATIENT ORDER USED IS VERIFIED WITH A PHARMACY PRODUCT AND THE FORMULATION USED DOES NOT EXACTLY MATCH THE DOSE. A FORMULATION FACTOR OF MORE OR LESS THAN ONE IS USED TO ACHIEVE THE VOLUME AND THE ORDER IS THEN CONVERTED TO A PRESCRIPTION. FOR EXAMPLE, 500 MG = 1 TAB OR 250 MG TIMES 2 TABS = 500 MG. PATIENT CARE COULD BE ADVERSELY AFFECTED, AS A PATIENT COULD RECEIVE EITHER MORE OR LESS OF A MEDICATION THERAPY THAN INTENDED. CERNER HAS RECEIVED COMMUNICATION OF ORDER DISCREPANCIES DISCOVERED DURING A CHART REVIEW AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERNER MILLENNIUM POWERORDERS AND MED PROFILE SOFTWARE LNX CERNER CORP. 2001 THROUGH 2007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1