MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM CLINICAL REPORTING, DYNAMIC DOCUMENTATION,POWERCHART FRAMEWORK; SOFTWARE, PRODUCT CODE: LNX

Model Number ADMININSTRATION.90 THROUGH 122, SMART TEMPLATE WIZARD 1.4

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification ((b)(4)) on may 25, 2018 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner corporation will provide a follow-up report when the software modification 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 millennium clinical reporting®, dynamic documentation®, or powerchart®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with cerner's smart templates wizard intake and output component when utilized in cerner millennium clinical reporting®, dynamic documentation®, and powerchart®.The issue involves cerner millennium cerner millennium clinical reporting®, dynamic documentation®, and powerchart® and affects users that utilize the smart template wizard intake and output component to add the intake and output (i&o) volume into patient documentation.In cerner millennium, when the user's physical location is not in the same time zone as the client's hosted domain, the smart template could include additional volumes or omit volumes from the summarized values that occurred during the time offset between the two time zones.Patient care could be adversely affected if clinical decisions are made based on inaccurate i&o totals in the patient's documentation.Cerner has not received communication on any adverse patient events as a result of this issue.

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 millennium clinical reporting®, dynamic documentation®, or powerchart®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with cerner's smart templates wizard intake and output component when utilized in cerner millennium clinical reporting®, dynamic documentation®, and powerchart®.The issue involves cerner millennium cerner millennium clinical reporting®, dynamic documentation®, and powerchart® and affects users that utilize the smart template wizard intake and output component to add the intake and output (i&o) volume into patient documentation.In cerner millennium, when the user's physical location is not in the same time zone as the client's hosted domain, the smart template could include additional volumes or omit volumes from the summarized values that occurred during the time offset between the two time zones.Patient care could be adversely affected if clinical decisions are made based on inaccurate i&o totals in the patient's documentation.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification (flash18-0344-0) on may 25, 2018 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially impacted.Cerner distributed a flash notification (flash18-0344-1) on jun 28, 2018 to all potentially impacted client sites.The software notification was updated to include notification that a software modification has been developed and is available 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.

• Brand Name: CERNER MILLENNIUM CLINICAL REPORTING, DYNAMIC DOCUMENTATION,POWERCHART FRAMEWORK
• Type of Device: SOFTWARE, PRODUCT CODE: LNX
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 7549396
• MDR Text Key: 109517411
• Report Number: 1931259-2018-00008
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADMININSTRATION.90 THROUGH 122, SMART TEMPLATE WIZARD 1.4
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1