MAUDE Adverse Event Report: EPIC SYSTEMS CORPORATION EPIC; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Device Problem Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: EPIC
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): EPIC SYSTEMS CORPORATION
• MDR Report Key: 8465641
• MDR Text Key: 140600342
• Report Number: MW5085367
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Device Operator: No Information
• Patient Sequence Number: 1