FDA Adverse Event Other Summary report: N

BAXA EM 2400

MDR report key: 1392783 · Received May 19, 2009

Report

Report Number
MW5011175
Event Type
Other
Date Received
May 19, 2009
Date of Event
May 5, 2009
Report Date
May 19, 2009
Product Code
LHI
Report Source
Voluntary report
Reporter Location
UT, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

WHILE SETTING UP ONE OF THE BAXA EM 2400 PUMP, THE TUBING FOR MAGNESIUM 8% WAS PLUGGED INTO THE PORT ASSIGNED TO HEPARIN 100 UNIT/ML AND VISA VERSA. THE SECOND CHECK PERSON, WHO ALSO PRIMES THE MACHINE, DID NOT NOTICE THE SWITCH. IT WAS EVENTUALLY CAUGHT 12 HRS LATER WHEN SOMEONE NOTICED THE HEPARIN BAG WAS FULL AND THE MAGNESIUM BAG WAS EMPTY MORE THAN USUAL. THERE WERE NO PATIENTS WHO RECEIVED HEPARIN WHO SHOULD HAVE RECEIVED MAGNESIUM, BUT 16 PATIENTS WHO RECEIVED MAGNESIUM WHO SHOULD HAVE RECEIVED HEPARIN. FORTUNATELY, THE ORDERED HEPARIN WAS MINIMAL CONCENTRATION OF 1 UNIT/ML SOLUTIONS WHICH EQUATED TO VERY LOW AMOUNTS OF MAGNESIUM IN THE ERROR. ALL PATIENTS HAD A MAGNESIUM LEVEL DONE WITH 6 MILDLY ELEVATED LEVELS, THE MAX BEING 2.7. WE ARE VERY HIGH USERS OF THE BAXA PUMP EM 2400. WE USE TWO OF THE PUMPS AND MAKE ALL PRODUCTS PER YEAR WITH THEM. WE ALSO USE TOTAL PORTS WHICH WE KNOW IS ABOVE THE AVERAGE USE. THIS IS THE SECOND TIME IN OUR HISTORY THAT THIS TYPE OF ERROR HAS OCCURRED - FIRST ONE ALSO REPORTED TO MEDWATCH OVER A YEAR AGO. BASED ON RCA CONDUCTED ON THIS ERROR, BESIDES THE INTERNAL THINGS FOUND, WE WISH THE MANUFACTURER TO CONSIDER THESE POTENTIAL IMPROVEMENTS: PORT NUMBERS MORE CLEARLY VISIBLE AND COLORED RATHER THAN RAISED CLEAR PLASTIC, BARCODED PORTS DURING SET UP, OPTION TO HAVE BAXA SELL PRE-SET UP PORTS AND TUBING, OR UNIQUE PORT CONNECTIONS OR TUBES TO HELP DISTINGUISH THEM APART.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BAXA EM 2400 BAXA TPN COMPOUNDER LHI

Patients

Seq Age Sex Outcome Treatment
1 Other