MAUDE Adverse Event Report: CERNER CORPORATION CERNER MEDICATION DECISION SUPPORT; SOFTWARE

Model Number 88809, 90888, 92329, 93562, 97570,100009,102070, 104999, 124755, 161087

Device Problem Computer Software Problem (1112)

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

Event Date 03/07/2022

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification june 10, 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.The software notification includes a description of the issue and a software modificationis 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 medication clinical decision support (cmds), 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 medication clinical decision support.The issue involves cerner's medication clinical decision support and affects users that utilize the specific logical domain filtering for medication alerts to suppress medication alerts for allergy, drug or duplicate therapy.Patient care could be adversely affected, if a medication alert is not displayed to the clinician and the clinician gives the patient medications that cause an allergy, interaction, or duplication of therapy.This issue could result in medication overdose/underdose.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification june 10, 2022 to all potentially impacted client sites.The software notification includes a description of the issue and notice that a software modification is being developed to address the issue for all sites that could be potentially impacted.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 another flash notification on february 9, 2023 to all potentially impacted client sites advising that a resolution was made available for the issue.Cerner corporation considers this issue to be resolved and no further narrative is required.

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 medication clinical decision support (cmds), 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 medication clinical decision support.The issue involves cerner's medication clinical decision support and affects users that utilize the specific logical domain filtering for medication alerts to suppress medication alerts for allergy, drug or duplicate therapy.Patient care could be adversely affected, if a medication alert is not displayed to the clinician and the clinician gives the patient medications that cause an allergy, interaction, or duplication of therapy.This issue could result in medication overdose/underdose.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER MEDICATION DECISION SUPPORT
• 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: 14675317
• MDR Text Key: 301645905
• Report Number: 1931259-2022-00007
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88809, 90888, 92329, 93562, 97570,100009,102070, 104999, 124755, 161087
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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