MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM INPATIENT PHARMACY, POWERORDERS, AND POWERPLANS; SOFTWARE

Model Number 2012.01 - 2018.01

Device Problem Computer Software Problem (1112)

Patient Problem Overdose (1988)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on june 29, 2018 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.

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 millennium inpatient pharmacy, powerorders®, and powerplans®, 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, powerorders, and powerplans dosage calculator.The issue involves cerner millennium inpatient pharmacy, powerorders, and powerplans and affects users that utilize dosage calculator to calculate medication dosage.When a user clicks "apply" multiple times in dosage calculator, the system uses an incorrect date of birth to calculate estimated values for creatinine clearance (crcl), ideal body weight (ibw), and body surface area (bsa), which produces incorrect values.When these incorrect values are used to calculate medication doses, the system calculates an incorrect dose.This issue could result in a patient receiving the incorrect dosage of medication.Cerner has received communication that this issue may have contributed to an adverse patient event that led to a patient receiving an incorrect dose of carboplatin.The outcome of this event was not communicated to cerner.

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 millennium inpatient pharmacy, powerorders®, and powerplans®, 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, powerorders, and powerplans dosage calculator.The issue involves cerner millennium inpatient pharmacy, powerorders, and powerplans and affects users that utilize dosage calculator to calculate medication dosage.When a user clicks "apply" multiple times in dosage calculator, the system uses an incorrect date of birth to calculate value for adjusted body weight (abw), body surface area (bsa), creatinine clearance (crcl), glomerular filtration rate (gfr), ideal body weight (ibw), and lean body weight (lbw) in cerner-standard, customized cerner-standard, and site-defined algorithms, which produces incorrect values.When these incorrect values are used to calculate medication doses, the system calculates an incorrect dose for the patient.Cerner has received communication that this issue may have contributed to an adverse patient event that led to a patient receiving an incorrect dose of carboplatin.The outcome of this event was not communicated to cerner.

Manufacturer Narrative

Cerner distributed an initial flash notification (flash18-0433-0) on june 29, 2018 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 final flash notification (flash18-0433-4) on november 21, 2018 to all potentially impacted sites.This software notification includes a description of the issue and the software modifications that have been developed to fully address the issue for all sites that could be potentially impacted.

• Brand Name: CERNER MILLENNIUM INPATIENT PHARMACY, POWERORDERS, AND POWERPLANS
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 7661670
• MDR Text Key: 113426639
• Report Number: 1931259-2018-00010
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2012.01 - 2018.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention