FDA Adverse Event Injury Summary report: N

SUNRISE ECLYPSIS

MDR report key: 2163546 · Received July 9, 2011

Report

Report Number
MW5021309
Event Type
Injury
Date Received
July 9, 2011
Date of Event
July 4, 2011
Report Date
July 9, 2011
Manufacturer
ALLSCRIPTS
Product Code
NSX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IN OUR FACILITY, THE CPOE PALATE OF THE UNIVERSE OF ORDERS ENABLE THE ORDERING OF CONCENTRATIONS OF DRUGS IN PRE-MIXED BAGS. THUS, INSTEAD OF SIMPLY ORDERING A FIXED DOSE OF DOPAMINE AT E.G. 5 MCG/KG/MINUTE WITH THE EQUIPMENT POPULATING THE WEIGHT FIELD, MULTIPLE CLICKS ARE REQUIRED TO SELECT THE DESIRED CONCENTRATION OF THE PRE-MIXED BAG, AND THEN ENTER THE DOSING DRIP RATE AND WEIGHT -SIC-. IF THERE IS A NEED TO USE THIS DRUG IN SYNERGY WITH ANOTHER, THE DESCRIPTIVE INDIVIDUALIZATION OF DIRECTIONS IS NOT FEASIBLE. IN OUR CASE OF ACUTE COMPLEX CLASS 4 HEART FAILURE WITH HYPOTENSION, A CONCENTRATED PRE-MIX OPTION WAS SELECTED DUE TO USER (A PHYSICIAN) CONFUSION, INEXPERIENCE, OR MISS-CLICK. THE ORDER WAS NOT EXECUTED UNTIL "CLARIFICATION" (THE ORIGINAL ORDER WAS AS CLEAR AS THE CPOE TRANSMITTED IT), WHICH DELAYED THE INITIATION OF THE THERAPY BY 3.25 HOURS. THIS DELAY RENDERED THE HEART FAILURE MORE DIFFICULT TO TREAT DUE TO ADVERSE BODY CHEMISTRY CHANGES THAT PROGRESSED DURING THE DELAY, THREATENING THE PT'S LIFE. THE ORDERING PROGRAMS ON THIS EQUIPMENT IS DANGEROUS, USER-UNFRIENDLY, ERROR PRONE, AND IS AN IMPEDIMENT TO INDIVIDUALIZING MEDICAL CARE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SUNRISE ECLYPSIS CPOE AND EMR NSX ALLSCRIPTS

Patients

Seq Age Sex Outcome Treatment
1 55 YR Life Threatening