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

MAUDE Adverse Event Report: CERNER CORPORATIONCERNER MILLENNIUM PHARMACY MEDMANAGER

  • 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 PHARMACY MEDMANAGER   Back to Search Results
Event Date 01/18/2007
Event Type  Malfunction   Patient Outcome  Hospitalization
Manufacturer Narrative

Cerner has distributed a priority review flash notification july 26, 2007 to all potentially impacted client sites. The software notification includes a description of the issue and an interim workflow adjustment to prevent the malfunction. Additionally, a script was provided to identify orders impacted by this issue. A software modification has been developed and is available to address the issue for all sites that could be potentially impacted. Cerner corporation considers this issue resolved and no further narrative is required for follow-up.

 
Event Description

The issue involves the pharmacy medmanager functionality. If the user performs a modify action on an order with an existing duration and duration unit, the order's stop date might not be recalculated. Specifically, this occurs when only the duration value is changed prior to entering the original duration unit. Pt care could be adversely affected, as medication therapy could be concluded prematurely or could last longer than intended based on the order details prior to the modification. This issue can be avoided if the user performs a renew action instead of a modify action to change an order's duration. If performing a modify action is required, users can manually set the stop date and time during the modify action. Cerner received communication that a pt's surgery required rescheduling as a result of this issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCERNER MILLENNIUM PHARMACY MEDMANAGER
Type of DeviceMEDMANAGER
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 (Section G)
Manufacturer Contact
shelley looby
2800 rockcreek pkwy.
kansas city , MO 64117
(816) 201 -1368
Device Event Key866781
MDR Report Key888215
Event Key850586
Report Number1931259-2007-00003
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 07/30/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2007
Is This An Adverse Event Report? Yes
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 Manufacturer? No
Date Manufacturer Received01/18/2007
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/31/2006
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: 07/30/2007 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
-
-