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

Model Number 2007.19 THROUGH 2018.01

Device Problem Computer Software Problem (1112)

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

Event Date 11/26/2021

Event Type  malfunction  

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 affects users that place, review, and approve medication orders within the electronic medical record.The issue occurs when a user orders a medication with a pharmacy priority of stat or now and then intends to modify the order.Instead of selecting "modify" the user selects "copy".Upon realizing that was incorrect, the user cancels that action and selects "modify" and signs the original order.This workflow may result in an additional administration being added to medication administration record before the next scheduled dose administration.Patient care may be affected if a patient receives an additional dose of an intended medication.Cerner has received communication of an adverse patient event where one patient received two doses of insulin and it was confirmed that the patient was not harmed due to the second dose of insulin.

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 2022 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.

• Brand Name: CERNER MILLENNIUM POWERORDERS AND PLANS
• 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: 13320102
• MDR Text Key: 294645126
• Report Number: 1931259-2022-00001
• 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: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/21/2022

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: 2007.19 THROUGH 2018.01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2009
• 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