BEUDAMED
    FDA Adverse Event Other Summary report: N

    CERNER MILLENNIUM POWERORDERS

    MDR report key: 3581686 · Received January 6, 2014

    Report

    Report Number
    1931259-2013-00010
    Event Type
    Other
    Date Received
    January 6, 2014
    Date of Event
    November 19, 2013
    Report Date
    January 6, 2014
    Manufacturer
    CERNER CORP.
    Product Code
    OUG
    PMA / PMN Number
    NA
    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 PR14-01-0 ON JANUARY 2, 2014 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE FLASH NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, NOTIFICATION OF UPDATES MADE TO RELATED LABELING TO CLARIFY THE SYSTEM'S PREFERENCE OF VOLUME OVER STRENGTH FOR PRODUCT-LEVEL HOME MEDICATIONS, AND ADD'L INSTRUCTIONS TO ENSURE THAT ALL INSTRUCTIONS ARE UNDERSTOOD BY PTS. THE FLASH NOTIFICATION ALSO INCLUDES NOTIFICATION OF A SAFETY ENHANCEMENT IN DEVELOPMENT TO PROVIDE DATABASE ADMINISTRATORS FUNCTIONALITY TO IDENTIFY SYNONYMS THAT SHOULD DISPLAY STRENGTH, RATHER THAN VOLUME, ON AN INDIVIDUAL BASIS. CERNER CORPORATION WILL PROVIDE A F/U REPORT WHEN THE SAFETY ENHANCEMENT IS AVAILABLE.

    Description of Event or Problem · 1

    THIS ISSUE INVOLVES CERNER MILLENNIUM POWER/ORDERS. WHEN AN ORIGINATING MEDICATION ORDER HAS BOTH A VOLUME AND STRENGTH AND IS CONVERTED TO A PRODUCT-LEVEL HOME MEDICATION, CERNER MILLENNIUM POWER ORDERS WAS DESIGNED TO DISPLAY VOLUME AND NOT THE STRENGTH DOSE FOR PRODUCT-LEVEL HOME MEDICATIONS ON THE RESULTING PRESCRIPTION'S DISCHARGE REPORTS AND INSTRUCTIONS. USING THE VOLUME DOSE TYPICALLY REDUCES THE NEED FOR THE PT TO DETERMINE HOW MUCH IS NEEDED (FOR EXAMPLE, ONE TABLET). ALL DOSAGE INFO PROVIDED ON THE DOCUMENTATION IS ACCURATE. PT CARE MAY BE AFFECTED IF A PT ADMINISTERS AN INCORRECT DOSE RESULTING FROM CONFUSION IF A MEDICATION PRESCRIBED DISPLAYS A DOSE FORMAT NOT MATCHING THE DOSE FORMAT PROVIDED ON THE DISCHARGE DOCUMENTATION WITHOUT PROVIDING ADD'L INSTRUCTIONS. CERNER HAS RECEIVED COMMUNICATIONS OF PTS BEING ADMITTED DUE TO THIS ISSUE. NO ADD'L INFO RELATED TO THESE EVENTS HAS BEEN PROVIDED BY REPORTING CLIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7114 CERNER MILLENNIUM POWERORDERS SOFTWARE OUG CERNER CORP. 2007.19-2012.01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other