MAUDE Adverse Event Report: CERNER CORPORATION HOMEWORKS BUSINESS MANAGEMENT; SOFTWARE

Model Number 5.11.2

Device Problems Defective Device (2588); Application Program Problem: Medication Error (3198)

Patient Problems Overdose (1988); Underdose (2542)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification on may 3, 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 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 homeworks® business management, 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 homeworks® business management.The issue involves cerner homeworks® business management and affects users that utilize homeworks® business management applications or roadnotes® to enter or review a medication order.  in cerner homeworks®, when the user enters a medication order with a future start date, the medication frequency that is displayed within the medication order string may not match the medication frequency in the medication order.  patient care could be adversely affected, as clinicians may not have the full details of a medication before reviewing or administering the medication.This issue could result in medication overdose or under dose due to incorrect frequency of administration.Cerner has not received communication on any adverse patient events as a result of this issue. .

• Brand Name: HOMEWORKS BUSINESS MANAGEMENT
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rock creek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 8595200
• MDR Text Key: 161506621
• Report Number: 1931259-2019-00001
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5.11.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2019
• 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