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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION POWERORDERS AND PLANS; SOFTWARE
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CERNER CORPORATION POWERORDERS AND PLANS; SOFTWARE Back to Search Results
Model Number 2007.19 - 2018.01
Device Problem Computer Software Problem (1112)
Patient Problems Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2020
Event Type  Injury  
Manufacturer Narrative
Cerner distributed a flash notification on july 23rd 2020 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 powerorders and plans, 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 powerorders and plans.The issue involves cerner millennium powerorders and plans and affects users that utilize the powerorders and plans to place clinical orders within the emr.In cerner millennium, when the user modifies the phase duration for an initiated pending powerplan or modify the stop date and time for an initiated powerplan phase, the updated stop date and time are not applied to components with the duration linked to the phase.As a result, patient care may be affected if treatments are not stopped at the appropriate time and patients may receive additional doses of medication or unnecessary tests may be performed.Cerner has received communication that a patient was moved to critical care after they received duplicate blood thinning therapy due to 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 power orders and plans, 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 power orders and plans.The issue involves cerner millennium power orders and plans and affects users that utilize the power orders and plans to place clinical orders within the emr.In cerner millennium, when the user modifies the phase duration for an initiated pending power plan or modify the stop date and time for an initiated power plan phase, the updated stop date and time are not applied to components with the duration linked to the phase.As a result, patient care may be affected if treatments are not stopped at the appropriate time and patients may receive additional doses of medication or unnecessary tests may be performed.Cerner has received communication that a patient was moved to critical care after they received duplicate blood thinning therapy due to this issue.
 
Manufacturer Narrative
Cerner distributed a flash notification on july 23rd 2020 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 distributed a flash notification on december 08,2020 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.
 
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Brand Name
POWERORDERS AND PLANS
Type of Device
SOFTWARE
Manufacturer (Section D)
CERNER CORPORATION
2800 rock creek parkway
kansas city MO 64117
MDR Report Key10322359
MDR Text Key208204046
Report Number1931259-2020-00008
Device Sequence Number1
Product Code LNX
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Notification
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2007.19 - 2018.01
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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