MAUDE Adverse Event Report: CERNER CORPORATION CONNECT NURSING; SOFTWARE

Model Number ALL CONNECT NURSING RELEASES

Device Problem Computer Software Problem (1112)

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

Event Date 08/03/2023

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 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 the connect nursing to view and acknowledge new orders and results as well as complete medication administration.While completing medication administration, connect nursing allows to configure settings in order catalog tool that require users to capture witness signatures before administering some medications.In order catalog tool, the witness required default value determines whether witness signatures are required before administering that specific medication.If witness required default value is configured, witness required exception values also can be defined which indicate the scenarios where the witness required default value does not apply for that medication.The two options available for both witness required default values and witness required exception values are: required or not required.When custom scripts are used to import medication synonym information into order catalog tool and the imported witness required default and witness required exception values defined for a medication share the same value, this same values cause the system to operate in the opposite manner of what was originally intended.When users document medication administrations in medication administration cloud component, the system may not require users to capture witness signatures when appropriate or require users to capture a witness signature in situations where witness signatures are not normally required.Patient care could be adversely affected, if the system does not require collection of a witness signature for the administration of a medication that should require a witness signature.This could cause a patient medication error when additional medication verification from witness signature is not completed.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on october 11, 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.

Manufacturer Narrative

Cerner distributed a flash notification on october 11, 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 updated flash notification on january 8, 2024 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 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 the connect nursing to view and acknowledge new orders and results as well as complete medication administration.While completing medication administration, connect nursing allows to configure settings in order catalog tool that require users to capture witness signatures before administering some medications.In order catalog tool, the witness required default value determines whether witness signatures are required before administering that specific medication.If witness required default value is configured, witness required exception values also can be defined which indicate the scenarios where the witness required default value does not apply for that medication.The two options available for both witness required default values and witness required exception values are: required or not required.When custom scripts are used to import medication synonym information into order catalog tool and the imported witness required default and witness required exception values defined for a medication share the same value, this same values cause the system to operate in the opposite manner of what was originally intended.When users document medication administrations in medication administration cloud component, the system may not require users to capture witness signatures when appropriate or require users to capture a witness signature in situations where witness signatures are not normally required.Patient care could be adversely affected, if the system does not require collection of a witness signature for the administration of a medication that should require a witness signature.This could cause a patient medication error when additional medication verification from witness signature is not completed.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: 17985915
• MDR Text Key: 326565877
• Report Number: 1931259-2023-00014
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALL CONNECT NURSING RELEASES
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2023
• 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