RECALL: Abacus TPN Software Dosing Errors

Abacus software users have reported a number of errors as a result of ordering salt based parenteral nutrition ingredients on an ion based ordering template. Abacus total parenteral nutrition (TPN) Calculation Software is designed and intended to allow the ordering of electrolytes in only one of two ways: as a salt (eg, calcium gluconate 10%) or as an elemental ion (eg, calcium). However, if a dosage is entered into the system based on one method, when the template is configured for the other method, a dosing error can occur.

The Abacus TPN Calculating Software is an FDA Class I Laboratory Information Management System (LIMS) Windows-based program used in ordering total parenteral nutrition.On January 23, 2009, Baxa Corporation alerted its customers to ensure that users create either a salt-based template or an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were also instructed to establish ingredient warning limits and to have pharmacists sign off if a warning limit is exceeded. In 2009 and 2010, Baxa issued updates that added limit warnings to the Abacus software.

The problem associated with salt-based or ion-based ordering of electrolytes affects the following catalog numbers:

  • 8300-0045: Abacus Calculator Only (Abacus CE)
  • 8300-0046: Abacus Single Work Station (Abacus SE)
  • 8300-0047: Abacus Multi-Work Station (Abacus ME)

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305762.htm.