• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION CERNER MILLENNIUM POWERCHART MEDICATION PROFILE SOFTWARE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

CERNER CORPORATION CERNER MILLENNIUM POWERCHART MEDICATION PROFILE SOFTWARE Back to Search Results
Event Date 02/21/2006
Event Type  Malfunction  
Event Description

The issue involves the medication profile tab, used within the powerchart office and powerchart core systems. When a multiple-ingredient, continous infusion order is placed in pharmacy medication manager, the medication profile tab does not display all of the components of the order; instead the system displays only the diluent orderable item (the rxmnemonic). This also happens to regular medication orders placed in pharmacy medication manager. Companyn has not been made aware of any adverse patient care events that resulted from this issue.

 
Manufacturer Narrative

Cerner has distributed a priority review flash notification march 10, 2006 to all potentially impacted client sites. The software notification includes a description of the issue and advises clients of an interim workflow adjustment to prevent the malfunction. A software modification is being developed and will be available to address the issue for all sites that could be potentially impacted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCERNER MILLENNIUM POWERCHART MEDICATION PROFILE
Type of DeviceSOFTWARE
Manufacturer (Section F)
CERNER CORPORATION
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer (Section D)
CERNER CORPORATION
2800 rockcreek pkwy.
kansas city MO 64117
Manufacturer Contact
shelley looby
2800 rockcreek parkway
kansas city , MI 64117
(816) 201 -1368
Device Event Key678128
MDR Report Key688925
Event Key655610
Report Number1931259-2006-00001
Device Sequence Number1
Product CodeNSX
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 03/13/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/13/2006
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1999
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 Invalid Data

Patient TREATMENT DATA
Date Received: 03/13/2006 Patient Sequence Number: 1
-
-