MAUDE Adverse Event Report: CERNER CORPORATION POWERORDERS AND PLANS; SOFTWARE

Model Number 2018.01.09 - 2018.02.02

Device Problem Application Program Problem: Medication Error (3198)

Patient Problems Overdose (1988); Underdose (2542); Missed Dose (2561)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on january 30, 2020 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's powerorders and plans®, 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 powerorders and plans®.The issue involves cerner millennium powerorders and plans® and affects users that utilize the powerorders to submit orders for new prescriptions or change or cancel existing prescriptions.If the prescribing service that routes prescriptions to foreign system interfaces (fsis) with the pharmacy fails to route these new, changed, or cancelled prescriptions, the powerorders system may not notify providers when these failures to route to the pharmacy occur.Patient care could be adversely affected if physicians are not notified when a new prescription, change to a prescription, or cancellation of a prescription fails to route to the pharmacy so that other communication methods to the pharmacy may be used.The issue could result in patients receiving a medication that was meant to be discontinued, multiple instances of the same medication, or not receiving a medication they need to continue to take.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's power orders and plans®, 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 power orders and plans®.The issue involves cerner millennium power orders and plans® and affects users that utilize the power orders to submit orders for new prescriptions or change or cancel existing prescriptions.If the eprescribing service that routes prescriptions to foreign system interfaces (fsis) with the pharmacy fails to route these new, changed, or cancelled prescriptions, the power orders system may not notify providers when these failures to route to the pharmacy occur.Patient care could be adversely affected if physicians are not notified when a new prescription, change to a prescription, or cancellation of a prescription fails to route to the pharmacy so that other communication methods to the pharmacy may be used.The issue could result in patients receiving a medication that was meant to be discontinued, multiple instances of the same medication, or not receiving a medication they need to continue to take.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on january 30, 2020 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 follow-up flash notification on april 21, 2020 to all potentially impacted clients.This notification includes an update to the list of affected software as well as the availability of the software modification developed to address the issue for all sites that could be potentially impacted.Cerner corporate considers this issue to be resolved and no further narrative is required for follow-up.

• Brand Name: POWERORDERS AND PLANS
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city, mo MO 64117
• MDR Report Key: 9673730
• MDR Text Key: 214800225
• Report Number: 1931259-2020-00002
• 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: Notification
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: 2018.01.09 - 2018.02.02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1