MAUDE Adverse Event Report: CERNER CORPORATION POWERORDERS AND PLANS, VTE PREVENTION; SOFTWARE

Model Number 2015.01 - 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem Hematoma (1884)

Event Date 11/03/2021

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.This report documents information related to an issue identified with functionality included in cerner's millennium powerplans® and vte prophylaxis advisor.The issue affects users that utilize the vte prophylaxis advisor to provide corresponding treatment recommendations.In cerner millennium, when the user manually delays a pharmacologic recommendation in vte prophylaxis advisor, the powerplan may display the original start date and time.If the order is signed with the original start date and time displayed, a patient could receive medication earlier than intended.Patient care could be adversely affected if the delay timeframe is not honored in the new order.It is possible the patient may receive the medication too soon.Cerner has received communication that a patient received a dose of an anticoagulant earlier than intended and the patient developed a hematoma.

Manufacturer Narrative

Cerner distributed a flash notification on december 22, 2021 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.

• Brand Name: POWERORDERS AND PLANS, 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: shelley looby ; 8779 hillcrest road; kansas city, MO 64138 ; 8162011368
• MDR Report Key: 13082984
• MDR Text Key: 286673129
• Report Number: 1931259-2021-00020
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 - 2018.01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2014
• 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
• Patient Outcome(s): Hospitalization