FDA Adverse Event Other Summary report: N

EHR SYSTEM

MDR report key: 4317208 · Received December 4, 2014

Report

Report Number
MW5039414
Event Type
Other
Date Received
December 4, 2014
Report Date
September 15, 2014
Product Code
LNX
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

RECENTLY, IT CAME OT OUR ATTENTION THE BPOC SYSTEM HAS A GAPING HOLE RELATIVE TO THE SAFE ADMINISTRATION OF IV MEDICATIONS. WE BELIEVE THE REPORTED ISSUE MAY HAVE HAPPENED WITH AN UPGRADE BUT CAN NOT BE CERTAIN. WHEN PREPARING COMPOUNDED IV MEDICATIONS, THE COMPONENTS OF THE IV ARE BARCODE VERIFIED AGAINST THE CPOE ORDER TO ENSURE CORRECT PRODUCT SELECTION PRIOR TO MIXING. THIS SCAN INCLUDES THE CARRIER SOLUTION AND ANY ADDITIVES. THIS SYSTEM HAS BEEN RELIABLE SINCE IMPLEMENTATION 7 YEARS AGO. AT THE BEDSIDE, THIS NURSE IS EXPECTED TO SCAN THE BARCODE ON THE PATIENT LABEL WHICH REFERENCES THE SPECIFIC RX # OF THE ORDER. THIS MATCHES THE CORRECT IV PRODUCT DIRECTLY TO THE PATIENT. HOWEVER, WE WERE RECENTLY MADE AWARE WHEN A NURSE SCANS THE CARRIER SOLUTION BARCODE AT THE BEDSIDE HE/SHE RECEIVES POSITIVE CONFIRMATION OF THE CORRECT PRODUCT. WHAT THIS MEANS IS EVERY PRODUCT MIXED IN 100 ML OF 0.9% NORMAL SALINE, FOR EXAMPLE, WOULD GIVE THE SAME FEEDBACK IF THE CARRIER SOLUTION BARCODE IS SCANNED. AS A QUICK FIX, WE HAVE STARTED TO OBSCURE THE CARRIER SOLUTION BARCODE SO THE NURSES ONLY HAVE ONE BARCODE ON THE PRODUCT, THAT BEING THE RX # BARCODE. WE ARE SUBMITTING A PATIENT SAFETY TASK TO OUR EHR VENDOR AS WELL. THIS BEGS THE QUESTION, WHAT ARE WE MISSING DURING TESTING FOR UPGRADES AND HOW MANY OTHER LATENT ERRORS ARE IN THE EHR SYSTEMS. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
784748 EHR SYSTEM EHR SYSTEM LNX

Patients

Seq Age Sex Outcome Treatment
1