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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION INPATIENT PHARMACY; SOFTWARE,
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CERNER CORPORATION INPATIENT PHARMACY; SOFTWARE, Back to Search Results
Model Number 2018.01
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
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 inpatient pharmacy®, 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® pharmacy medication manager.The issue involves cerner millennium inpatient pharmacy and affects users that utilize the pharmacy medication manager to enter pharmacy orders and manage drug therapy for a patient.In cerner millennium, when the next scheduled administration time for a medication order is skipped or changed in pharmacy medication manager, the order's start time and the first scheduled administration task time in mar are changed to later than intended.Patient care could be adversely affected, as patient may receive dose later than intended due to incorrect administration time on medication order.This issue could result in patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.
 
Manufacturer Narrative
Cerner distributed a flash notification on june 10, 2021 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.
 
Manufacturer Narrative
Cerner distributed a flash notification on june 10, 2021 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 september 16, 2021 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 inpatient pharmacy®, 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® pharmacy medication manager.The issue involves cerner millennium inpatient pharmacy and affects users that utilize the pharmacy medication manager to enter pharmacy orders and manage drug therapy for a patient.In cerner millennium, when the next scheduled administration time for a medication order is skipped or changed in pharmacy medication manager, the order's start time and the first scheduled administration task time in mar are changed to later than intended.Patient care could be adversely affected, as patient may receive dose later than intended due to incorrect administration time on medication order.This issue could result in patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.
 
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Brand Name
INPATIENT PHARMACY
Type of Device
SOFTWARE,
Manufacturer (Section D)
CERNER CORPORATION
2800 rock creek parkway
kansas city MO 64117
MDR Report Key11983162
MDR Text Key281520187
Report Number1931259-2021-00011
Device Sequence Number1
Product Code LNX
Combination Product (y/n)Y
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 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2018.01
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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