MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM MEDICATION ADMINISTRATION WIZARD; SOFWARE

Model Number 2015.01 - 2018.01

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on july 3, 2019 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 medication administration wizard®, 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 medication administration wizard® medication charting.The issue involves cerner millennium medication administration wizard and affects users that utilize the medication charting to document patient medication administration.In cerner millennium, when the user scans a product barcode that contains only a strength or volume for a free-text medication order and the dose or dose unit charting element is specified for an ingredient, the medication charting window displays the volume charting element for the ingredient as blank and but required causing the user to enter a value, which may be inaccurate.When a specific preference is set and a dose or dose units are both specified for the ingredient and a volume is entered, the system performs a validation check on the volume value, which prevents the users from charting the administration.Additionally, when a specific preference is set and the dose or dose unit are both specified for the ingredient, the volume element displays an incorrect calculated value, which also prevents the users from charting the administration.This issue could result in a patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER MILLENNIUM MEDICATION ADMINISTRATION WIZARD
• Type of Device: SOFWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rock creek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 8788955
• MDR Text Key: 209176358
• Report Number: 1931259-2019-00004
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 - 2018.01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1