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

Model Number 2018.07 THROUGH 2018.11

Device Problem Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2022

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 powerorders and plans®, 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 powerorders and plans.The issue involves cerner millennium powerorders and plans and affects users that utilize powerorders to place and manage medication orders.In cerner millennium, when a user copies an intermittent order within a powerplan, the values for the rate, infuse over, and total volume details are not carried forward to the new order.If the rate, infuse over and total volume details were previously adjusted and were not updated in the new order, patient care may be affected if a patient receives a medication at an incorrect rate of administration.Cerner was made aware that patient experienced side effects when a chemo medication was administered with an incorrect rate and infuse over values.The rate and infuse over values had previously been modified for the patient and when the order was copied, the rate and infuse over values did not carry over.Once the caregivers realized the patient was experiencing side effects, the chemo treatment was stopped and the side effects subsided and the patient did not require any additional medical intervention.

Manufacturer Narrative

Cerner distributed a flash notification on april 18, 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.

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 has been developed to address the issue for all sites that could be potentially impacted.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 powerorders and plans®, 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 powerorders and plans.The issue involves cerner millennium powerorders and plans and affects users that utilize powerorders to place and manage medication orders.In cerner millennium, when a user copies an intermittent order within a powerplan, the values for the rate, infuse over, and total volume details are not carried forward to the new order.If the rate, infuse over and total volume details were previously adjusted and were not updated in the new order, patient care may be affected if a patient receives a medication at an incorrect rate of administration.Cerner was made aware that patient experienced side effects when a chemo medication was administered with an incorrect rate and infuse over values.The rate and infuse over values had previously been modified for the patient and when the order was copied, the rate and infuse over values did not carry over.Once the caregivers realized the patient was experiencing side effects, the chemo treatment was stopped and the side effects subsided and the patient did not require any additional medical intervention.

• Brand Name: POWERORDERS AND PLANS
• 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: 14208806
• MDR Text Key: 294874678
• Report Number: 1931259-2022-00005
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2018.07 THROUGH 2018.11
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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