FDA Adverse Event Summary report: N

MEDICAL DEVICE DATA SYSTEM

MDR report key: 6986625 · Received October 30, 2017

Report

Report Number
MW5073015
Date Received
October 30, 2017
Report Date
August 30, 2017
Manufacturer
EPIC SYSTEMS
Product Code
OUG
Report Source
Voluntary report
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

MEDICATION ORDER FOR CAFFEINE CITRATE. OUR EPIC BUILD HAS CAFFEINE CITRATE ORDER BASED ON "CAFFEINE BASE". THE PRODUCT STOCKED IN THE PHARMACY MAKES NO REFERENCE ON THE LABEL ABOUT "CAFFEINE BASE". CAFFEINE CITRATE INJECTION WHICH OUR STAFF USED FOR ORAL USE IS LABELED AS 60 MG/ 3 ML. (OUR STAFF DID NOT REALIZE WE DO IN FACT STOCK THE ORAL CAFFEINE CITRATE, WHICH I FOUND ON THE ORAL LIQUIDS SHELF THE MORNING AFTER THE EVENT.) THE ORDER WAS ENTERED AS CAFFEINE BASE HOWEVER THE VOLUME DRAWN UP WAS TOTAL CAFFEINE BASED ON LABEL CONCENTRATION AND AS A RESULT, THE NEONATE WAS UNDERDOSED. ADDITIONALLY, WE MADE A REQUEST AT THE SYSTEM LEVEL TO CORRECT THIS BUILD AS WE SHARE THE "COMPUTER RECORD" WITH OTHER SYSTEM HOSPITALS AND THIS LEAD TO DISCUSSIONS WITH NEONATOLOGISTS, PHARMACY, INFORMATICS AND SYSTEM LEVEL CHANGES AND EDUCATION TO FOLLOW WITH EPIC BUILD CHANGES. HERE IS EMAIL SENT TO OUR PEDIATRICIAN SPECIALIST: HI DR. (B)(6), I AM SENDING YOU THIS EMAIL TO ASK YOU ABOUT CURRENT LITERATURE AND BEST PRACTICE RECOMMENDATIONS WITH RESPECT TO ORDERING CAFFEINE CITRATE IN NEONATES. THERE WAS A MEDICATION EVENT LAST EVENING AND AFTER EXTENSIVE REVIEW AND MANY SWISS CHESSE HOLES LINING UP THE BABY RECEIVED A LOWER THAN ORDERED DOSE OF CAFFEINE CITRATE. WITHOUT GOING INTO TOO MUCH DETAIL FOR NOW; BESIDES TO STATE THAT 18 MG CAFFEINE BASE WAS ORDERED AND PATIENT RECEIVED 18 MG CAFFEINE CITRATE WHICH IS ONLY 9 MG CAFFEINE BASE; I AM WONDERING WHAT THE BEST PRACTICE RECOMMENDATIONS ARE IN THE NEONATAL LITERATURE ABOUT PLACING ORDERS FOR CAFFEINE CITRATE? FROM MY RESEARCH THIS MORNING, IT APPEARS THAT THE CAFFEINE SHOULD BE ORDERED AS TOTAL CAFFEINE CITRATE AND OUR EPIC BUILD IS BY CAFFEINE BASE. THE DRUG PRODUCT NO LONGER LISTS THE AMOUNT OF CAFFEINE BASE IN THE PRODUCT AND THE LITERATURE I REVIEWED STATED IT IS NOW RECOMMENDED TO PLACE ORDERS AS CAFFEINE CITRATE. IF THERE IS A SHIFT IN PRACTICE, I WOULD LIKE TO WORK TO CORRECT THE INFORMATION IN EPIC FOR ACCURATE BUILD AND LESS CONFUSION. THANK YOU FOR YOUR ATTENTION TO THIS AND I LOOK FORWARD TO SEEING YOU TOMORROW MORNING AT THE (B)(6) MEETING. PLEASE LET ME KNOW IF THERE ARE ANY QUESTIONS. MEDICATION ADMINISTERED TO OR USED BY THE PATIENT: YES. OUTCOME: THE ORDER WAS ENTERED AS CAFFEINE BASE HOWEVER THE VOLUME DRAWN UP WAS TOTAL CAFFEINE BASED ON LABEL CONCENTRATION AND AS A RESULT, THE NEONATE WAS UNDER DOSED. WHERE DID THE ERROR OCCUR: HOSPITAL. WHEN AND HOW WAS ERROR DISCOVERED: OUR STAFF DID NOT REALIZE WE DO IN FACT STOCK THE ORAL CAFFEINE CITRATE, WHICH I FOUND ON THE ORAL LIQUIDS SHELF THE MORNING AFTER THE EVENT. PATIENT COUNSELING PROVIDED: UNK. PATIENT'S AGE: NEONATE (0-28 DAYS). REPORTER'S RECOMMENDATIONS: WE MADE A REQUEST AT THE SYSTEM LEVEL TO CORRECT THIS BUILD AS WE SHARE THE "COMPUTER RECORD" WITH OTHER SYSTEM HOSPITALS AND THIS LEAD TO DISCUSSIONS WITH NEONATOLOGISTS, PHARMACY, INFORMATICS AND SYSTEM LEVEL CHANGES AND EDUCATION TO FOLLOW WITH EPIC BUILD CHANGES. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
765948 MEDICAL DEVICE DATA SYSTEM MEDICAL DEVICE DATA SYSTEM OUG EPIC SYSTEMS

Patients

Seq Age Sex Outcome Treatment
1