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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER ABACUS SOFTWARE
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BAXTER ABACUS SOFTWARE Back to Search Results
Device Problem Application Program Problem: Dose Calculation Error (1189)
Patient Problem No Patient Involvement (2645)
Event Type  Other  
Event Description
Background: we use abacus software to mix our tpn's, and we also carry clinimix-e5/20 premade tpn/s, 2000 ml size.For proper and consistent labeling, we run all of our tpn's through abacus, including clinimix-e orders.We also add lipids to all of our tpns to make them 3-in-1, a concentration of 125 ml lipids per liter tpn.This means that the 2000 ml clinimix bags, we add 250 ml lipids for all clinimix tpn orders.Problem: an order was received yesterday to add "10 units of regular insulin per liter of tpn".The tpn was running at 80 ml per hour.The patient happened to be receiving a clinimix-e 5/20 tpn, a 2000 ml bag, to which we add 250 ml of lipids to make a lipid concentration of 125 ml lipids per liter tpn.It was discovered that the abacus software calculates the amount of insulin incorrectly.For an insulin concentration of 10 units per liter tpn, 22.5 units of insulin is the correct amount that should be added (2.25 liters of tpn, order for 10 units per liter).However, the abacus software calculates the insulin based on 2000 ml, the size of the premixed bag, instead of the size of the bag after we add the lipids.This creates an error of 12.5%.Apparently, this is a known problem that baxter hasn't fixed.Medication not administered to or used by the patient.(b)(6).
 
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Brand Name
ABACUS SOFTWARE
Type of Device
ABACUS SOFTWARE
Manufacturer (Section D)
BAXTER
MDR Report Key5406460
MDR Text Key37439275
Report NumberMW5059934
Device Sequence Number1
Product Code JQP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 06/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/01/2016
Type of Device Usage N
Patient Sequence Number1
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