EPIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for EPIC manufactured by Epic Systems Corporation.

Event Text Entries

[140600342] My hospital switched to epic in (b)(6) 2018. I have heard many nurses express concern regarding being able to calculate the dosage when a change is required. There has been a lot of confusion around the idea that the nomogram will say increase or decrease by units/kg/hr. I was told i incorrectly changed a heparin dose. Normally the rate is determined by a nomogram for high or low dose based on the ptt. My manager said this was supposed to be a continuous rate with no need to check ptt unless specifically ordered. I explained that for me to change the rate i would have needed to see the nomogram to figure it out. After 2 meetings the manager of the floor told me that even after speaking with epic there was no way to determine what i saw on the screen. Upon discussing this with a staff representative, there have been several incidences with errors adjusting heparin. Nurses were increasing the rate by 2 ml/hr instead of 2 units/kg/hr. It was also noted that even when the nomogram indicated a change and the previous nurse properly did change the rate, the next time a new bag was hung or another rate change was indicated, the rate showing on the administration page would be different than the rate showing on the signature page. While making these changes there are several warnings that are generated by the change and the calculated rate. My idea, which i think would be helpful for all high risk medications, would be to require a second signature for each warning or over-ride. This would allow 2 people to look at the nomogram and verify the calculation and change. From experience the primary nurse will show the second nurse the labs, and how they arrived at the calculation, instead of having a check at each step with the second nurse verifying each step is accurate. Also if there is a question of how the rate or change was calculated, there is a time stamp at each stage. (b)(4). Email: email protected.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085367
MDR Report Key8465641
Date Received2019-03-28
Date of Report2019-01-03
Date Added to Maude2019-03-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
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 NameBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Product CodeMMH
Date Received2019-03-28
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerEPIC SYSTEMS CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-28

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