EPIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-06 for EPIC manufactured by Epic Systems Corporation.

Event Text Entries

[62124594] The cpoe system, epic, is one of the largest in the united states. Epic has an inherent problem: orders for medication show up in the medication administration charting (mar) section in an erroneous, and, i believe, confusing and possible dangerous manner. The mar, and the label that issues from the printer in epic, confuses product strength with dose. For example, a 3 mg daily dose of sirolimus appears as "sirolimus tablet 3 mg; dose 3 mg oral daily. Sirolimus is not marketed in a 3 mg tablet. Similarly, any dose of a product that does not exactly match the tablet strength appears in the same confusing pattern: e. G. , a dose of mesalamine capsules 1600 mg appears as "mesalamine capsule 1600 mg dose 1600 mg etc. " mesalamine is not marketed as a 1600 mg capsule. The above should read, correctly, in the mar (and on labels) as: sirolimus tablet (or tablets) 1 mg, dose 3 mg, and mesalamine capsule (or capsules) 400 mg, dose 1600 mg, etc. This inherent software error has widespread distribution, i believe, and should be rectified. My attempts to point out this problem have been ignored locally. Severity: circumstances or events have capacity to cause error. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5066600
MDR Report Key6157633
Date Received2016-12-06
Date of Report2016-09-06
Date Added to Maude2016-12-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEPIC
Generic NameMEDICAL COMPUTER AND SOFTWARE
Product CodeMMH
Date Received2016-12-06
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEPIC SYSTEMS CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2016-12-06

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