FDA Adverse Event Summary report: N

EHR SYSTEMS

MDR report key: 8206281 · Received December 28, 2018

Report

Report Number
MW5082681
Date Received
December 28, 2018
Report Date
June 22, 2018
Manufacturer
EPIC SYSTEMS CORPORATION
Product Code
OUG
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

UNIVERSAL PACKAGE LABEL CAUSES CONFUSION ABOUT INGREDIENTS IN A MEDICATION: PEDIATRIC PATIENT WITH MULTIPLE FOOD ALLERGIES, INCLUDING PINEAPPLE. GOLYTELY WAS PRESCRIBED FOR BOWEL CLEANOUT. PHARMACIST OBTAINED THE PRODUCT AND ENSURED THAT THERE WAS NO FLAVORING, ETC. ORDER WAS DISCONTINUED AND REORDERED WITHIN AN HOUR OF DISPENSING FIRST DOSE; ANOTHER JUG WAS DISPENSED. THE SUBSEQUENT JUG THAT WAS SENT CONTAINED BOTH NATURAL AND ARTIFICIAL PINEAPPLE FLAVORING. THIS JUG WAS NOT STARTED AS THE RN RECOGNIZED IT CONTAINED PINEAPPLE. PHARMACY REPLACED IT WITH A NON-PINEAPPLE JUG. OVER THE COURSE OF RECEIVING GOLYTELY, THE PATIENT HAD EXPERIENCED FACIAL SWELLING AND CAREGIVER WAS CONCERNED FOR AN ALLERGIC REACTION. PATIENT RECEIVED DIPHENHYDRAMINE AND STEROIDS. THE PATIENT FINISHED HER BOWEL CLEANOUT WITH POLYETHYLENE GLYCOL PACKETS WHICH ARE NOT FLAVORED. IT WAS DETERMINED AFTER THAT THE PATIENT¿S FACIAL SWELLING WAS LIKELY DUE TO THE TAPE HOLDING HER NG TUBE IN PLACE. UPON REVIEW OF WHICH GOLYTELY JUGS WERE DISPENSED BY THE PHARMACY TO THIS PATIENT, TWO UNFLAVORED AND TWO PINEAPPLE FLAVORED JUGS HAD BEEN DISPENSED, BUT FOLLOWING DISCUSSION WITH NURSES AND PHARMACISTS WORKING AT THIS TIME, IT WAS DETERMINED THE PATIENT WAS NOT ADMINISTERED ANY OF THE PINEAPPLE FLAVORED PRODUCT. UNTIL INVESTIGATION INTO EXACTLY WHICH NDCS WERE DISPENSED THOUGH, THERE WAS CONFUSION ABOUT THE INGREDIENTS IN GOLYTELY GIVEN THE MANUFACTURER USES A UNIVERSAL PACKAGE INSERT AND INCLUDES THE INGREDIENTS OF ALL FORMULATIONS ( FLAVORED AND NON-FLAVORED IN THE SAME INSERT). GOING FORWARD WE ARE ATTEMPTING TO BLOCK PURCHASE OF FLAVORED GOLYTELY BUT THIS CAN PROVE DIFFICULT AT TIMES IN CASES OF SHORTAGE ETC. A CURRENT LIMITATION OF HER SYSTEMS, AT LEAST EPIC FOR US, IS THAT IT DOES NOT HAVE THE FUNCTIONALITY TO CHECK A PATIENT¿S ALLERGIES E.G. FOOD/DYE ALLERGIES AGAINST INACTIVE INGREDIENTS IN A MEDICATION. GIVEN THERE ARE SO MANY FORMULATIONS OF MEDICATIONS AND PHARMACY STOCK ROTATES OFTEN, IT WOULD BE DIFFICULT FOR THE SYSTEM TO DO THIS THUS IT REQUIRES HYPER-VIGILANCE BY THE PHARMACIST AND NURSE. SEE SCANNED PAGES. WHERE DID THE ERROR OCCUR: HOSPITAL. SEVERITY: ERROR OCCURRED; MEDICATION DID NOT REACH PATIENT.(B)(6), ACCESS NUMBER: (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1043450 EHR SYSTEMS MEDICAL DEVICE DATA SYSTEM OUG EPIC SYSTEMS CORPORATION

Patients

Seq Age Sex Outcome Treatment
1