FDA Adverse Event Injury Summary report: N

ABACUS

MDR report key: 2108083 · Received May 24, 2011

Report

Report Number
MW5020731
Event Type
Injury
Date Received
May 24, 2011
Date of Event
May 21, 2011
Report Date
May 24, 2011
Manufacturer
BAXA CORP.
Product Code
NEP
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

PT, A PREMATURE NEONATE IN NEONATAL ICU. PT RECEIVING TOTAL PARENTERAL NUTRITION (TPN). TPN COMPOUNDED USING BAXA AUTOMATED COMPOUNDER WITH ABACUS SOFTWARE. DEXTROSE IS ORDERED AT HOSP AS DEXTROSE IN MG/KG/MINUTE TPN SOLUTION, EACH BAG, TO BE INFUSED OVER A DURATION OF 24 HOURS. ENTIRE ORDER (ALL ORDERED COMPONENTS) ENTERED INTO COMPUTER CORRECTLY. "DURATION" OF INFUSION ENTRY LINE WAS 24 HOURS PER USUAL ROUTINE. OPERATOR ERROR: LINE FOR ENTRY OF "PERIOD" (DEFINED BY BAXA AS THE TIME PERIOD WITHIN WHICH A BAG WOULD BE RUN) IN THIS CASE, IT SHOULD HAVE BEEN A BAG INFUSED OVER 24 HOUR DURATION, EVERY 24 HOURS "PERIOD". THE NUMBER IN THIS "PERIOD" LINE (WHICH IS CHANGEABLE BUT NEVER CHANGED AT THE HOSPITAL) WAS INADVERTENTLY CHANGED TO "4." THIS RESULTED IN AN AUTOMATIC RE-CALCULATION OF THE DEXTROSE COMPONENT OF THE TPN SUCH THAT THE PUMP WOULD DELIVER 6 TIMES MORE DEXTROSE THAN ENTERED. THE LABEL THAT IS PRINTED BY THE PROGRAM LISTED THE COMPONENTS AS ENTERED (INCLUDING DEXTROSE 6 MG/KG/MIN) BUT DID CHANGE THE GIR FROM 6 TO 36, CHANGED KCAL AND CHANGED OSMOLARITY. THE RPH AND RN DOUBLE CHECK THE TPN LABEL VERSUS THE ORIGINAL PHYSICIAN ORDER BY LOOKING AT THE LISTED COMPONENTS ON THE LABEL, INCLUDING THE DEXTROSE RATE (UNCHANGED AND CORRECT AT 6 MG/KG/MIN), BUT DO NOT ROUTINELY CHECK THE GIR AS IT SHOULD BE THE SAME AS THE DEXTROSE INFUSION RATE. THUS THE LABEL IS NOT CONSISTENTLY CHANGED WHEN THIS AUTOMATIC RE-CALCULATION OCCURS, LEADING TO FALSE CONFIRMATION OF CORRECT ADDED DEXTROSE. AFTER THE RN DOUBLE CHECKED THE TPN AND CONFIRMED THE DEXTROSE RATE AS 6 MG/KG/MIN (BUT NOT THE GIR), IT WAS STARTED ON THE PT. SOME 3-4 HOURS LATER A BLOOD GLUCOSE (BG) WAS MEASURED AT APPROXIMATELY 450 MG/DL, THEN RE-MEASURED AND CONFIRMED. THE PT HAD MULTIPLE BGS OVER 600 MG/DL, INSULIN WAS STARTED WITH GRADUAL NORMALIZATION OF THE BG. DURING THE ENTIRE EPISODE THE CHILD REMAINED VIGOROUS AND WITHOUT CLINICALLY OBVIOUS ILL EFFECTS. IN SUMMARY, A CHANGE IN A SELDOM USED AND POORLY DEFINED ORDER ENTRY CELL IN A TPN COMPOUNDER PROGRAM "PERIOD" RESULTED IN AUTOMATIC RE-CALCULATION OF THE TPN CONTENTS WITH SIGNIFICANT INCREASE IN DEXTROSE ADDED TO THE TPN. THIS AUTOMATIC CHANGE WAS LARGELY TRANSPARENT, NO DOSE LIMIT ALERTS OCCURRED AND WAS HARD TO DETECT WHEN COMPARING LABEL TO ORDER. THE DEXTROSE INFUSION RATE IN MG/KG/MIN STATED ON THE LABEL DID NOT CHANGE ALTHOUGH THE GIR DID (THEY SHOULD BE IDENTICAL). THIS INCONSISTENCY MADE THE LABEL "LOOK" CORRECT WHEN DOUBLE CHECKED VERSUS THE ORDER. THE MFR WAS CONTACTED AND THE FOLLOWING CHANGES BEING MADE: THE "PERIOD" ENTRY "LOCKED" TO 24; THE DURATION ENTRY DEFAULTS TO 24 AND "ALERT" OCCURS IF CHANGED; EVALUATING LABEL FORMAT TO DETERMINE HOW "GIR" CAN BE MORE APPARENT; INTERNAL HOSPITAL SYSTEM CHANGES BEING IMPLEMENTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ABACUS BAXA COMPOUNDER PHARMACY ENTRY PROGRAM NEP BAXA CORP. NA

Patients

Seq Age Sex Outcome Treatment
1 3 DA Disability