MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM POWERCHART, FIRSTNET, AND SURGICAL POWERCHART; SOFTWARE

Model Number N/A

Device Problems Application Program Problem (2880); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: CERNER MILLENNIUM POWERCHART, FIRSTNET, AND SURGICAL POWERCHART
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 7340958
• MDR Text Key: 102458583
• Report Number: 1931259-2018-00003
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1