MAUDE Adverse Event Report: CERNER CORPORATION INPATIENT PHARMACY; SOFTWARE

Model Number 2015.01 - 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification (flash19-0625-0) on october 2, 2019 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 inpatient pharmacy®, 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 inpatient pharmacy® pharmacy medication manager.This issue applies to clinicians who use dose range checking in cerner's millennium inpatient pharmacy® pharmacy medication manager.When the user places medication orders for a patient using a product with a defined lifetime dose range, dose range checking may exclude previous administrations, dispenses, or documented outside administrations, causing the system to fail to display a dose range alert when a dose exceeds the lifetime cumulative dose.In addition, a dose range alert may display an incorrect value for how much a dose exceeds the lifetime limit.Patient care is affected if a patient continues to receive a medication in excess of the maximum recommended lifetime dose.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 inpatient pharmacy®, 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 inpatient pharmacy® pharmacy medication manager.This issue applies to clinicians who use dose range checking in cerner's millennium inpatient pharmacy® pharmacy medication manager.When the user places medication orders for a patient using a product with a defined lifetime dose range, dose range checking may exclude previous administrations, dispenses, or documented outside administrations, causing the system to fail to display a dose range alert when a dose exceeds the lifetime cumulative dose.In addition, a dose range alert may display an incorrect value for how much a dose exceeds the lifetime limit.Patient care is affected if a patient continues to receive a medication in excess of the maximum recommended lifetime dose.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification (flash19-0625-1) on february 6, 2020 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: INPATIENT PHARMACY
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city, mo MO 64117
• MDR Report Key: 9145889
• MDR Text Key: 214800238
• Report Number: 1931259-2019-00007
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2015.01 - 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1