MAUDE Adverse Event Report: CERNER CORPORATION SEPSIS; SOFTWARE

Model Number ALL THE RELEASES

Device Problem Computer Software Problem (1112)

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

Event Date 10/17/2023

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 rare 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 sepsis®, 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 sepsis®.The issue involves cerner millennium sepsis and affects a small number of users that utilize the cloud based product sepsis to get the discern notifications for the care team of the patients with sepsis symptoms.In cerner millennium, a sepsis notification may not be displayed for a patient experiencing sepsis signs or symptoms.The sepsis crawler gathers information from millennium tables and sends the information to healtheintent to be used in the cloud-based sepsis algorithms.In some circumstances, the sepsis inclusion criterion may be suppressed and affect whether a sepsis notification is displayed.If sepsis inclusion criterion is suppressed, a sepsis notification may not be displayed for a patient experiencing sepsis signs or symptoms and vice-versa.Patient care could be adversely affected, if sepsis inclusion or exclusion criterion are incorrectly suppressed by the system, unnecessary sepsis notifications are displayed or necessary sepsis notifications are missing.Users are regularly advised to not make care decisions based solely on whether a sepsis notification is displayed.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on (b)(6) 2024 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.

• Brand Name: SEPSIS
• 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: 18699958
• MDR Text Key: 336414071
• Report Number: 1931259-2024-00001
• 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
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALL THE RELEASES
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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