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

Model Number 2015.01 - 2018.05

Device Problem Computer Software Problem (1112)

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

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on may 28, 2021 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 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® and affects users that utilize the product to copy forward an existing iv set to create a new iv set.If the original iv set components were created in an older software release and were copied forward in a later release with a certain preference enabled (iv_favoriteordered_as_synonym), the system may not copy forward all the iv set components to the new iv set orderable item.Patient care could be adversely affected if the new iv set does not include all the intended components and is administered to a patient.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: POWERORDERS AND PLANS
• Type of Device: SOFTWARE
• 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: 11913224
• MDR Text Key: 253570317
• Report Number: 1931259-2021-00009
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 - 2018.05
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2018
• 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