MAUDE Adverse Event Report: CERNER CORPORATION MPAGES; SOFTWARE

Model Number MPAGES 6.12 - 6.14

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on january 10, 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.

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 mpages®, 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 mpages® opioid review.The issue involves cerner millennium mpages and affects users that utilize the opioid review to prescribe orders.When a physician places a primary opioid inpatient or prescription order using powerorders, for medications with multiple morphine milligram equivalent (mme) conversion factors, the mme column may display an incorrect value which may be used for future opioid order decision making.Patient care can be affected if a physician prescribes or does not prescribe opioid medication to a patient based on incorrect opioid ordering information.The issue is limited to the following medications: buprenorphine, butorphanol, fentanyl, hydromorphone, meperidine, and morphine.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on june 18,2020 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 mpages®, 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 mpages® opioid review.The issue involves cerner millennium mpages and affects users that utilize the opioid review to prescribe orders.When a physician places a primary opioid inpatient or prescription order using power orders, for medications with multiple morphine milligram equivalent (mme) conversion factors, the mme column may display an incorrect value which may be used for future opioid order decision making.Patient care can be affected if a physician prescribes or does not prescribe opioid medication to a patient based on incorrect opioid ordering information.The issue is limited to the following medications: buprenorphine, butorphanol, fentanyl, hydromorphone, meperidine, and morphine.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MPAGES
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city, mo MO 64117
• MDR Report Key: 9593862
• MDR Text Key: 204194719
• Report Number: 1931259-2020-00001
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPAGES 6.12 - 6.14
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1