BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERNER MILLENNIUM POWERCHART, FIRSTNET, AND SURGICAL POWERCHART

    MDR report key: 7340958 · Received March 15, 2018

    Report

    Report Number
    1931259-2018-00003
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 19, 2018
    Report Date
    August 23, 2018
    Manufacturer
    CERNER CORPORATION
    Product Code
    LNX
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CERNER DISTRIBUTED A FLASH NOTIFICATION (FLASH18-0152-0) ON MARCH 7, 2018 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THIS NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, A REMINDER THAT THE MAXIMUM_CHARTS PREFERENCE BE SET TO 1 (ONE) AND AN EXPLANATION THAT THE INVESTIGATION IS ONGOING TO IDENTIFY THE CAUSE OF THE ISSUE. CERNER DISTRIBUTED A FLASH NOTIFICATION (FLASH18-0152-5) ON AUGUST 22, 2018 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE AND A SOFTWARE MODIFICATION HAS BEEN DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION CONSIDERS THIS ISSUE TO BE RESOLVED AND NO FURTHER NARRATIVE IS REQUIRED FOR FOLLOW-UP.

    Description of Event or Problem · 0

    THE SOFTWARE PRODUCT MENTIONED IN THIS MEDWATCH REPORT MAY NOT BE, BY DEFINITION, A MEDICAL DEVICE; HOWEVER, CERNER HAS CHOSEN TO FILE THIS MEDWATCH REPORT IN ORDER TO VOLUNTARILY NOTIFY THE FDA OF A MALFUNCTION ASSOCIATED WITH THIS SOFTWARE PRODUCT. THE COMPANY'S FILING OF THIS MEDWATCH REPORT DOES NOT SIGNIFY CERNER'S BELIEF OR UNDERSTANDING THAT MEDICAL DEVICE REPORTS ARE REQUIRED TO BE FILED FOR PRODUCTS SUCH AS CERNER'S MILLENNIUM POWERCHART®, FIRSTNET®, AND SURGICAL POWERCHART®, NOR ARE THESE PRODUCTS CURRENTLY ACTIVELY REGULATED BY THE FDA. THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S MILLENNIUM EMR. IF A USER HAS MULTIPLE PATIENT CHARTS OPEN AT THE SAME TIME, THE ACTIVE PATIENT CHART MAY CHANGE UNEXPECTEDLY TO ANOTHER OPEN PATIENT CHART WHEN THE USER PERFORMS ACTIONS IN THE CHART THEY WERE ORIGINALLY VIEWING. THE INFORMATION IN THE DEMOGRAPHICS BAR, WHICH DISPLAYS IDENTIFYING INFORMATION ABOUT THE PATIENT, WILL DISPLAY THE CORRECT PATIENT DEMOGRAPHIC INFORMATION FOR THE NOW-ACTIVE PATIENT CHART. ALSO, WHEN MULTIPLE PATIENT CHARTS ARE OPEN, EACH CHART IS DISPLAYED WITH A DIFFERENT COLOR BACKGROUND FOR IDENTIFYING PURPOSES. THIS ISSUE CAN OCCUR IF THE MAXIMUM_CHARTS INSTITUTION PREFERENCE IS SET TO A VALUE GREATER THAN 1 (ONE). THIS PREFERENCE CONTROLS THE NUMBER OF CHARTS THAT CAN BE OPEN AT ONE TIME. CERNER'S RECOMMENDATION IS TO HAVE THE MAXIMUM_CHARTS PREFERENCE SET TO 1, WHICH ALIGNS WITH THE JOINT COMMISSION RECOMMENDATION. THIS ISSUE COULD ALSO OCCUR WITH VERSIONS 12.6 THROUGH 12.8 OF CITRIX RECEIVER USED WITH AN APPLE MACINTOSH (MAC) OPERATING SYSTEM. PATIENT CARE COULD BE AFFECTED IF A USER TAKES ACTION FOR AN UNINTENDED PATIENT DUE TO ANOTHER OPEN PATIENT CHART DISPLAYING UNEXPECTEDLY. CERNER HAS RECEIVED A REPORT OF THE ISSUE POTENTIALLY CONTRIBUTING TO A CLINICIAN ADMINISTERING MEDICATION TO AN INCORRECT PATIENT. THE MEDICATION ADMINISTRATION MAY HAVE CONTRIBUTED TO THIS PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    CERNER DISTRIBUTED A FLASH NOTIFICATION ((B)(4)) ON MARCH 7, 2018 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THIS NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, A REMINDER THAT THE MAXIMUM_CHARTS PREFERENCE BE SET TO 1 (ONE) AND AN EXPLANATION THAT THE INVESTIGATION IS ONGOING TO IDENTIFY THE CAUSE OF THE ISSUE. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE ROOT CAUSE OF THE ISSUE IS IDENTIFIED AND A PERMANENT CORRECTION IS AVAILABLE.

    Description of Event or Problem · 1

    THE SOFTWARE PRODUCT MENTIONED IN THIS MEDWATCH REPORT MAY NOT BE, BY DEFINITION, A MEDICAL DEVICE; HOWEVER, CERNER HAS CHOSEN TO FILE THIS MEDWATCH REPORT IN ORDER TO VOLUNTARILY NOTIFY THE FDA OF A MALFUNCTION ASSOCIATED WITH THIS SOFTWARE PRODUCT. THE COMPANY'S FILING OF THIS MEDWATCH REPORT DOES NOT SIGNIFY CERNER'S BELIEF OR UNDERSTANDING THAT MEDICAL DEVICE REPORTS ARE REQUIRED TO BE FILED FOR PRODUCTS SUCH AS CERNER'S MILLENNIUM POWERCHART®, FIRSTNET®, AND SURGICAL POWERCHART®, NOR ARE THESE PRODUCTS CURRENTLY ACTIVELY REGULATED BY THE FDA. THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S MILLENNIUM EMR. IF A USER HAS MULTIPLE PATIENT CHARTS OPEN AT THE SAME TIME, THE ACTIVE PATIENT CHART MAY CHANGE UNEXPECTEDLY TO ANOTHER OPEN PATIENT CHART WHEN THE USER PERFORMS ACTIONS IN THE CHART THEY WERE ORIGINALLY VIEWING. THE INFORMATION IN THE DEMOGRAPHICS BAR, WHICH DISPLAYS IDENTIFYING INFORMATION ABOUT THE PATIENT SUCH AS NAME, DATE OF BIRTH, ALLERGIES, MEDICAL RECORD NUMBER, ETC. WILL DISPLAY THE CORRECT DEMOGRAPHIC INFORMATION FOR THE NOW-ACTIVE PATIENT CHART. ALSO, WHEN MULTIPLE PATIENT CHARTS ARE OPEN, EACH CHART IS DISPLAYED WITH A DIFFERENT COLOR BACKGROUND FOR IDENTIFYING PURPOSES. THIS ISSUE CAN OCCUR IF THE MAXIMUM_CHARTS INSTITUTION PREFERENCE IS SET TO A VALUE GREATER THAN 1 (ONE). THIS PREFERENCE CONTROLS THE NUMBER OF CHARTS THAT CAN BE OPEN AT ONE TIME. CERNER'S RECOMMENDATION IS TO HAVE THE MAXIMUM_CHARTS PREFERENCE SET TO 1, WHICH ALIGNS WITH THE JOINT COMMISSION RECOMMENDATION. PATIENT CARE COULD BE AFFECTED IF A USER TAKES ACTION FOR AN UNINTENDED PATIENT DUE TO ANOTHER OPEN PATIENT CHART DISPLAYING UNEXPECTEDLY. CERNER HAS RECEIVED A REPORT OF THE ISSUE POTENTIALLY CONTRIBUTING TO A CLINICIAN ADMINISTERING MEDICATION TO AN INCORRECT PATIENT. THE MEDICATION ADMINISTRATION MAY HAVE CONTRIBUTED TO THIS PATIENT'S DEATH. THIS ISSUE IS STILL UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184546 CERNER MILLENNIUM POWERCHART, FIRSTNET, AND SURGICAL POWERCHART SOFTWARE LNX CERNER CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1