MAUDE Adverse Event Report: CERNER CORPORATION VTE PREVENTION; SOFTWARE

Model Number ALL THE RELEASES

Device Problem Computer Software Problem (1112)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on september 04, 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 vte prevention®, 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 ® vte prevention advisor.The issue involves cerner millennium vte prevention and affects users that utilize the vte prevention advisor to access the risk of venous thromboembolus (vte) in hospitalized adult patients, and provide risk stratified recommendations for therapy to prevent the occurrence of vte while in hospital.In cerner millennium vte prevention, the system was showing the default pharmacological contraindications that could result in patient getting medication if a clinician doesn't select the contraindication.This is due to vte risk factors which included in risk scores pharmacological contraindications, and mechanical contraindications, are missing some mapping to snomed and icd-10 codes.If a snomed or icd-10 code is documented for a patient and the code is not mapped to a condition group, the system does not recognize the code as a risk factor or contraindication, and the vte prophylaxis advisor will not display any documented risk factors, mechanical contraindications, or pharmacological contraindications.Patient care could be adversely affected, if clinicians do not document the appropriate risk factor or contraindications when using the vte prophylaxis advisor resulting in the presentation of incorrect recommendations.This could vary from no impact to significant impact.Cerner has not received communication on any adverse patient events as a result of this issue.

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 vte prevention®, 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 ® vte prevention advisor.The issue involves cerner millennium vte prevention and affects users that utilize the vte prevention advisor to access the risk of venous thromboembolus (vte) in hospitalized adult patients, and provide risk stratified recommendations for therapy to prevent the occurrence of vte while in hospital.In cerner millennium vte prevention, the system was showing the default pharmacological contraindications that could result in patient getting medication if a clinician doesn't select the contraindication.This is due to vte risk factors which included in risk scores pharmacological contraindications, and mechanical contraindications, are missing some mapping to snomed and icd-10 codes.If a snomed or icd-10 code is documented for a patient and the code is not mapped to a condition group, the system does not recognize the code as a risk factor or contraindication, and the vte prophylaxis advisor will not display any documented risk factors, mechanical contraindications, or pharmacological contraindications.Patient care could be adversely affected, if clinicians do not document the appropriate risk factor or contraindications when using the vte prophylaxis advisor resulting in the presentation of incorrect recommendations.This could vary from no impact to significant impact.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification on september 04, 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 an updated flash notification on april 30, 2024 to all potentially impacted client sites.The software notification includes a description of the issue and includes the software modification that is available 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.

• Brand Name: VTE PREVENTION
• 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: 18276712
• MDR Text Key: 329853741
• Report Number: 1931259-2023-00017
• 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: Notification
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2009
• 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