MAUDE Adverse Event Report: CERNER CORPORATION MEDICATION ADMINISTRATION RECORD; SOFTWARE

Model Number 2018.09 THROUGH 2018.14

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on 20/january/2023 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 record®, 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 record®.The issue involves cerner millennium medication administration record® and affects users that utilize the medication administration record (mar) to displays the medication, orders, tasks, and administrations for the selected time frame and selected order status for a specific patient.In cerner millennium, when the user modifies the order within the medication administration process, the system could duplicate the intake and output (i&o) volumes for the first hour of infusion.Patient care could be adversely affected if clinical decisions are made based on an incorrect fluid balance.This issue could result in delayed patient care.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MEDICATION ADMINISTRATION RECORD
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer (Section G): CERNER CORPORATION; 8779 hillcrest road; kansas city MO 64138
• Manufacturer Contact: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 16225403
• MDR Text Key: 309067155
• Report Number: 1931259-2023-00002
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2018.09 THROUGH 2018.14
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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