MAUDE Adverse Event Report: CERNER CORPORATION CONNECT NURSING; SOFTWARE

Model Number CONNECT NURSING USER INTERFACE (JANUARY 20, 2022) THROUGH (MARCH 24, 2022)

Device Problem Computer Software Problem (1112)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on 16 march, 2022 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 modernized connect nursing on an android device to administer medication to, collect specimens from or associate devices to a patient.The issue occurs after a patient is scanned or selected (patient a) and the device enters sleep mode or loses connectivity while the review screen is displayed.When a user wakes the device to return to the app, they are redirected to the patient list.If the user then scans or selects a different patient (patient b) and accesses medication administration, specimen collections, or device association, the activities or orders for patient a are displayed inappropriately.Patient care could be adversely affected, if the user administers a medication to, collects a specimen from, or associates a device to the incorrect patient.When this issue occurs, a medication that was ordered for patient a may be incorrectly administered to patient b and the administration is documented on the chart of patient a.Additionally, patient care may be affected if a collection ordered for patient a is collected from patient b.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) 2022 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 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 modernized connect nursing on an android device to administer medication to, collect specimens from or associate devices to a patient.The issue occurs after a patient is scanned or selected (patient a) and the device enters sleep mode or loses connectivity while the review screen is displayed.When a user wakes the device to return to the app, they are redirected to the patient list.If the user then scans or selects a different patient (patient b) and accesses medication administration, specimen collections, or device association, the activities or orders for patient a are displayed inappropriately.Patient care could be adversely affected, if the user administers a medication to, collects a specimen from, or associates a device to the incorrect patient.When this issue occurs, a medication that was ordered for patient a may be incorrectly administered to patient b and the administration is documented on the chart of patient a.Additionally, patient care may be affected if a collection ordered for patient a is collected from patient b.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: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 13840817
• MDR Text Key: 287553089
• Report Number: 1931259-2022-00003
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CONNECT NURSING USER INTERFACE (JANUARY 20, 2022) THROUGH (MARCH 24, 2022)
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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