BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER POWERORDERS

    MDR report key: 3060665 · Received March 26, 2013

    Report

    Report Number
    1931259-2013-00002
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    CERNER CORP.
    Product Code
    OUG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CERNER DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION (B)(4) ON (B)(6) 2013 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE FLASH INCLUDES A DESCRIPTION OF THE ISSUE AND NOTIFIES CLIENTS OF CERNER'S PLANS TO PROVIDE A SOFTWARE CORRECTION TO ADDRESS THE ISSUE. ADDITIONALLY, THE FLASH NOTIFIES CLIENTS OF CERNER'S RECOMMENDATIONS TO MITIGATE THE ISSUE INCLUDING SOFTWARE FUNCTIONALITY ALREADY AVAILABLE (INTERVAL CHECKING) TO VISUALLY DISPLAY A WARNING IF MEDICATION ORDERS ARE PLACED TOO CLOSE TOGETHER. CERNER CORP WILL PROVIDE A F/U REPORT WHEN THE SOFTWARE CORRECTION IS AVAILABLE.

    Description of Event or Problem · 1

    THE ISSUE INVOLVES THE CERNER MILLENNIUM POWERORDER AND AFFECTS USERS THAT UTILIZE THE ENHANCED DETAILS TAB FOR PROVIDER ORDER ENTRY. IN CERNER MILLENNIUM, THE SKIP ADMINISTRATION CHECK BOX IS UNAVAILABLE AND THE REVIEW SCHEDULE LINK IS NOT DISPLAYED WHEN YOU PLACE A NEW ORDER OR MODIFY NON-IV, INPATIENT OR AMBULATORY-IN-OFFICE MEDICATION WITH A SCHEDULED FREQUENCY SO THAT THE START DATE AND TIME IS NOT THE SAME AS THE CURRENTLY SELECTED TIME OF DAY, DAY OF WEEK, OR HYBRID FREQUENCY SCHEDULE DATE AND TIME. PT CARE COULD BE ADVERSELY AFFECTED, AS MEDICATION ORDER INTERVALS MAY BE PLACED TOO CLOSE TOGETHER. THIS ISSUE COULD RESULT IN MEDICATION OVERDOSE IF PTS RECEIVE AN UNINTENDED DOSE. CERNER HAS RECEIVED COMMUNICATION ON (B)(6) 2013 THAT TWO PTS HAD INAPPROPRIATE INTERVALS FOR MEDICATIONS ORDERED AND SUBSEQUENTLY ADMINISTERED THEM. IT IS UNCLEAR WHAT IMPACT THE INCORRECT DOSAGE OF THE MEDICATIONS HAD ON THESE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123157 CERNER POWERORDERS SOFTWARE OUG CERNER CORP. 2007.19-2012.01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1