EPIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for EPIC manufactured by Epic Systems Corporation.

Event Text Entries

[132795922] Our pharmacy recently changed how we dispense act-bag meds. Instead of sending the via, adapter, and ivf, we now just stock the vial in pvxis; nurse grabbed the adapter and ivf from their unit stock. When iv bags are scanned, epic just verifies the type of solution, and not the volume. I heard this will be fixed with the next upgrade. We had a nurse grab a 100 ml bag instead of a 50 ml bag of ns to dilute a pantoprazole infusion. The error was discovered after the patient received the wrong dose for 6 hours. We are now planning to have pharmacy go back to dispensing the bag/adapter/vial for continuous infusions (pantoprazole, diltiazem, amiodarone). The volume of the ivf still doesn't verify when a pharmacist scans it, but at least a pharmacist check the bag before it's dispensed. Interestingly, we're also switching iv pumps. Currently nurses select "antibiotic ivpb 50 ml" or "antibiotic ivpb 100 ml", but on the new pumps they will choose exact meds (e. G. Cefazolin in 50 ml). If the med is accidentally diluted in the wrong volume, the patient may either get the dose too quickly, or may only receive half of the dose. (b)(6); access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5082989
MDR Report Key8231602
Date Received2019-01-08
Date of Report2018-06-25
Date Added to Maude2019-01-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEPIC
Generic NameMEDICAL DEVICE DATA SYSTEM
Product CodeOUG
Date Received2019-01-08
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerEPIC SYSTEMS CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-08

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