EPIC FOUNDATION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for EPIC FOUNDATION SYSTEM manufactured by Epic.

Event Text Entries

[35425812] As we are validating the build of erxs within epic, we found an interesting bit of information. For ambulatory scripts for insulin u-500, it seems that epic's "foundation system" (the system that has recommendations/pre-built files on how to build drugs) has a build that is unique for u-500 which is not aligned with medication safety best practices. Epi's foundation system recommends to convert u-500 doses so that one may use a u-100 syringe. We are addressing this issue with our ehr team, endocrinology service, and diabetes nurse educations but felt that it is necessary to share since many institutions are/have transitioning/transitioned to epic. One plan is to link an order for (b)(6) syringes so both of these get ordered together. There are other challenges we expect from the diabetes nurse educators, but we will address them once we meet this week. Of note, this is erx live in the 2015 version so it would be ver obvious to epic who identified it since very few institutions are going live with this version. Coincidentally there are tow hospital systems in xxxxxxxx, xx that are going live with epic 2015. Patient counseling provided: unknown. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059025
MDR Report Key5350910
Date Received2016-01-05
Date of Report2015-11-16
Date Added to Maude2016-01-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEPIC FOUNDATION SYSTEM
Generic NameERX HOSP SYSTEM
Product CodeNSX
Date Received2016-01-05
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerEPIC


Patients

Patient NumberTreatmentOutcomeDate
10 2016-01-05

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