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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORP.CERNER MILLENNIUM POWERCHARTSOFTWARE

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CERNER CORP. CERNER MILLENNIUM POWERCHART SOFTWARE   Back to Search Results
Model Number 2004 THROUGH 2007
Event Date 12/19/2007
Event Type  Malfunction  
Manufacturer Narrative

Cerner has distributed a priority review flash notification 2008 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. 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 correction is available.

 
Event Description

The issue involves functionality in cerner millennium powerchart powerorders and affects users that utilize the medication administration record. If a pro re nata (prn) medication order is modified to a scheduled order and back to prn, the last given date and time are displayed incorrectly for the task. This issue occurs if an administration or event was documented while the medication was a non-prn order. The system does not recognize this administration as the previous administration, and incorrect info is displayed in the last given detail. Pt care could be affected if a clinician bases the last administration off of the incorrect last given date and time, as a medication dose could be given without the proper time interval between doses. Cerner has not received communication of any adverse pt events as a result of this issue.

 
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Brand NameCERNER MILLENNIUM POWERCHART
Type of DeviceSOFTWARE
Manufacturer (Section F)
CERNER CORP.
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer (Section D)
CERNER CORP.
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer Contact
shelley looby
2800 rockcreek pkwy.
kansas city , MO 64117
(816) 201 -1368
Device Event Key995466
MDR Report Key996685
Event Key955759
Report Number1931259-2008-00001
Device Sequence Number1
Product CodeLNX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 02/05/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2004 THROUGH 2007
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received01/09/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/30/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/05/2008 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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