MAUDE Adverse Event Report: CERNER CORPORATION CONNECT NURSING; SOFTWARE

Model Number ALL CONNECT NURSING (ANDROID) RELEASES

Device Problem Computer Software Problem (1112)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on june 08, 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 connect nursing®, 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 connect nursing®.The issue involves cerner millennium connect nursing and affects users that utilize connect nursing to review a patient's allergies, vital signs, laboratory results, history, and conditions.In cerner millennium, when the user scans the medications of the same formulary from two different batches with different delivery (extended-release vs immediate release), the incompatibility warning does not display to alert the user that the product scanned does not match the order.As a result, the incorrect formulation of a medication may be administered.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on june 08, 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 distributed a revised flash notification july 18, 2023 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that software modification has been released 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 connect nursing®, 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 connect nursing®.The issue involves cerner millennium connect nursing and affects users that utilize connect nursing to review a patient's allergies, vital signs, laboratory results, history, and conditions.In cerner millennium, when the user scans the medications of the same formulary from two different batches with different delivery (extended-release vs immediate release), the incompatibility warning does not display to alert the user that the product scanned does not match the order.As a result, the incorrect formulation of a medication may be administered.Cerner has not received communication on any adverse patient events as a result of this issue.

• 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: jeff mauzey ; 8779 hillcrest road; kansas city, MO 64138
• MDR Report Key: 17109378
• MDR Text Key: 317539761
• Report Number: 1931259-2023-00013
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALL CONNECT NURSING (ANDROID) RELEASES
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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