MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM POWERORDERS; SOFTWARE

Model Number RELEASE 2012.01.42 THROUGH 2015.01.07.

Device Problems Programming Issue (3014); Application Program Problem: Medication Error (3198)

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

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a priority review (b)(4) on may 11, 2016 to all potentially impacted client sites.The software notification includes a description of the issue, an alternative workflow and notification that 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 issue involves cerner millennium powerorders, when you place a prn orderable item with a one-time frequency, the stop date and time may not be removed.As a result, the orderable item may enter a completed status and be removed from the order profile before it can be administered.In some prn medications for varied medical conditions such as seizure medication can be administered as prn thus the potential for non-serious injury to the patient would be present.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER MILLENNIUM POWERORDERS
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rockcreek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 5678334
• MDR Text Key: 45888873
• Report Number: 1931259-2016-00008
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RELEASE 2012.01.42 THROUGH 2015.01.07.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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