MAUDE Adverse Event Report: CERNER CORPORATION CONNECT NURSING; SOFTWARE

Model Number 1.24.0

Device Problem Computer Software Problem (1112)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification october 30, 2023 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that on october 26, 2023, cerner returned production environments to a previous working version of medication charting cloud service.A software modification is being developed to address the issue for a later cloud version.Cerner 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 connect nursing, nor are these products currently actively regulated by the fda.The issue involves cerner connect nursing and affects users that use the medication administration cloud component.The issue occurred in scenarios where an ingredient was added to an intermittent medication order during pharmacy verification, and the order included a medication activity that had passed its scheduled due time.When users attempted to sign the medication activity in the medication administration cloud component, a nursing server error message was displayed and users were unable to sign the updated medication activity.This issue could result in patient care delay for medication administration as clinicians would need to use alternative methods to administer medications that may not contain the protection of the rights of medication administration.Cerner has not received communication on any adverse patient events as a result of this issue.

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 connect nursing, nor are these products currently actively regulated by the fda.The issue involves cerner connect nursing and affects users that use the medication administration cloud component.The issue occurred in scenarios where an ingredient was added to an intermittent medication order during pharmacy verification, and the order included a medication activity that had passed its scheduled due time.When users attempted to sign the medication activity in the medication administration cloud component, a nursing server error message was displayed and users were unable to sign the updated medication activity.This issue could result in patient care delay for medication administration as clinicans would need to use alternative methods to administer medications that may not contain the protection of the rights of medication administration.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification (b)(6) 2023 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that on (b)(6) 2023, cerner returned production environments to a previous working version of medication charting cloud service.Cerner distributed a revised flash notification (b)(6) 2024 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that software modification will be deployed via cloud services on (b)(6) 2024.Cerner corporation completed deployment of resolution on (b)(6) 2024 and considers this issue to be resolved and no further narrative is required.

• Brand Name: CONNECT NURSING
• 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: mr. mauzey ; 8779 hillcrest road; kansas city, MO 64138
• MDR Report Key: 18059489
• MDR Text Key: 327260563
• Report Number: 1931259-2023-00015
• 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,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1.24.0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2023
• 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