MAUDE Adverse Event Report: BAXTER CORP ABACUS VERSION 3.1

Model Number VERSION 3.1

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2014

Event Type  Other  

Event Description

Abacus- baxter software: neonatal tpn's template: pediatric mvi and cysteine (among other ingredients) have not reported osmolarities in the formulary, and this is causing a discrepancy in the total osmolarity calculation.Neonatal total parenteral nutrition solutions are administered peripherally, and the upper limit osmolarity in our institution is 1100 mosm/l.During baxter installation of abacus, several ingredients in our formulary were missing important info such as osmolarity.For a neonatal pt, miscalculating total osmolarity of the solution for a peripheral line may cause chemical thrombophlebitis (due to increased osmolarity) and overall pt discomfort at the infusion site.Pharmacist proceeded to enter a test (sample) neonatal order on abacus, and manually calculated the total osmolarity including cysteine (0.570 mosm/ml) and pedi mvi (0.678 mosm/l).The resulting number for the manual calculation was 1342 mosm/l and the result obtained by abacus (which means missing pediatric mvi and cysteine) was 1241 mosm/l.These results reflect that by omitting mvi and cysteine in the formulary, there is a discrepancy of 101 mosm/l for this specific order.Also, for adult tpn's, osmolarity info was missing for several of the tpn ingredients, and we had to contact the manufacturers of each iv product to provide us with that info and add it to abacus for accuracy.Baxter abacus formulary set up was incomplete, information was not verified for accuracy, and as a result our tpn total osmolarity solution calculations were inaccurate.Another issue is that tpn orders (central with minimum volume) that require addition of standard electrolytes are not calculated by abacus (system is not able to calculate minimum volume of standard electrolytes per liter of solution), forcing the user/pharmacist to perform manual calculations and add the manual calculation to the template set by abacus.Diagnosis or reason for use: tpn calculation software.

• Brand Name: ABACUS VERSION 3.1
• Type of Device: ABACUS
• Manufacturer (Section D): BAXTER CORP; englewood 80112
• MDR Report Key: 4330495
• MDR Text Key: 5256340
• Report Number: MW5039566
• Device Sequence Number: 1
• Product Code: JQP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/08/2014

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: Health Professional
• Device Model Number: VERSION 3.1
• Device Catalogue Number: ABACUS 3.1 ME
• Device Lot Number: 003512
• Other Device ID Number: 02VCEA82C6E14EB45BE9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other