Abacus Total Parenteral Nutrition (TPN) Calculation Software from Baxa
May 29, 2012
FDA and Baxa recently classified their recall of the Abacus total parenteral nutrition (TPN) calculation software due to the potential for dosing errors. This recall was initiated in 2009. Since that time, more than 90% of software users have taken steps to correct the problem. The Abacus software is designed to allow healthcare providers to order electrolytes as either a salt (eg, calcium gluconate 10%) or as an elemental ion (eg, calcium), using the correct order entry template. Dosing errors are possible if the user enters the order using one method, but uses an order template for the other method – that is, order is entered as a salt using the template for an elemental ion (or vice versa). For example, ordering 500 mg of 10% calcium gluconate = 5 mL of a 10% calcium gluconate solution, while ordering 500 mg of 10% calcium ion = 53.76 mL of calcium gluconate, or an excess of more than 10 times.
The affected software was manufactured between August 2006 and April 2009 and is available under the following catalog numbers:
- 8300-0045: Abacus Calculator Only (Abacus CE),
- 8300-0046: Abacus Single Work Station (Abacus SE), and
- 8300-0047: Abacus Multi-Work Station (Abacus ME).
In order to prevent dosing errors with this software, software users are asked to create either a salt-based or ion-based template for order TPNs, and establish systems for ensuring that both entry methods may not be used in the same template. Initially, users were also asked to establish warnings for ingredient amounts exceeding a specified limit, and require a pharmacist to sign off if the limit was exceeded. However, in 2009 and 2010, Baxa updated the Abacus software to include such limit warnings.
Software users may contact Baxa Technical Support at 1-800-678-2292 (24 hours/day, 7 days/week) for more information about this recall. Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm . Additional information is available at the following links:
- Medwatch Alert:
- Company Recall Notice:
May 29, 2012, University of Utah, Drug Information Service, Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT