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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORP. CERNER MILLENNIUM CARENET CAREADMIN SOFTWARE

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CERNER CORP. CERNER MILLENNIUM CARENET CAREADMIN SOFTWARE Back to Search Results
Event Date 04/21/2006
Event Type  Malfunction  
Manufacturer Narrative

Cerner has distributed a priority review flash notification may 2006 to all potentially impacted client sites. The software notification includes a description of the issue and will advise clients a software correction is available, how to obtain the correction and to implement these software modifications into their production. A software modification has been developed and is available to address the issue for all sites that could be potentially impacted. This issue is now considered resolved and no further narrative is necessary as a follow up.

 
Event Description

The issue involves the careadmin medication administration wizard used within the carenet system. When scanning a medication in careadmin, the system fails to recognize mckesson identifiers or other miscelaneous identifiers and properly identify the scanned product, which could result in the documentation of an incorrect dose in the careadmini window. In such situations, the system does not display overdose or underdose or route/form compatibility warnings as it should. Patients could receive an inappropriate dose of medication. Cermer has not been made aware of any adverse patient care events that resulted from this issue.

 
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Brand NameCERNER MILLENNIUM CARENET CAREADMIN
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 parkway
kansas city , MO 64117
(816) 201 -1368
Device Event Key705035
MDR Report Key715963
Event Key681577
Report Number1931259-2006-00004
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 05/15/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2006
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 Manufactured09/01/2001
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? No Answer Provided
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 05/15/2006 Patient Sequence Number: 1
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