MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM CARE ADMINISTRATION & CERNER MEDICATION ADMINISTRATION (MAR); SOFTWARE - NOT A MEDICAL DEVICE

Model Number 2007.19 - 2015.01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Overdose (1988)

Event Date 07/18/2016

Event Type  Death  

Manufacturer Narrative

Cerner distributed a priority review flash notification on august 1, 2016 to all potentially impacted client sites.The client notification includes a description of the functionality and notice that a safety enhancement is being developed.Cerner corporation will provide a follow-up report when the safety enhancement 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 millennium care administration or cerner millennium medication administration record (mar), nor are these products currently actively regulated by the fda.This report documents information related to functionality of cerner millennium care administration and cerner millennium medication administration record (mar).When a user opens the medication charting window from the medication administration record or medication administration wizard, the performed date box is active by default.If the user inadvertently presses a hot key (h, k, m, r, t, w, or y), then the date in the performed date box is populated.Cerner received a report of an adverse event where a user's inadvertent use of a hotkey in the performed date field may have contributed to patient receiving an additional dose of medication.

Manufacturer Narrative

Cerner distributed a priority review flash notification on august 1, 2016 to all potentially impacted client sites.The client notification includes a description of the functionality and notice that a safety enhancement is being developed.Cerner distributed a priority review flash notification on september 20, 2016 to all potentially impacted client sites.The client notification includes a description of the functionality and notice that the safety enhancement is available.Cerner corporation considers the 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.This report documents information related to functionality of cerner millennium care administration and cerner millennium medication administration record (mar).When a user opens the medication charting window from the medication administration record or medication administration wizard, the performed date box is active by default.If the user inadvertently presses a hot key (h, k, m, r, t, w, or y), then the date in the performed date box is populated.Cerner received a report of an adverse event where a user's inadvertent use of a hotkey in the performed date field may have contributed to patient receiving an additional dose of medication.

• Brand Name: CERNER MILLENNIUM CARE ADMINISTRATION & CERNER MEDICATION ADMINISTRATION (MAR)
• Type of Device: SOFTWARE - NOT A MEDICAL DEVICE
• 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: 5840092
• MDR Text Key: 50936769
• Report Number: 1931259-2016-00010
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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,Followup
• Report Date: 09/22/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 2007.19 - 2015.01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 08/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2009
• 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
• Patient Outcome(s): Death