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Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software: Class I Recall - Potential Dosing Errors

Fri, 05/25/2012 - 11:30am
U.S. Food & Drug Administration

AUDIENCE: Pharmacy, Risk Manager

ISSUE: A number of errors have been reported by Abacus software users as a result of ordering salt based parenteral nutrition ingredients on an ion based ordering template. Abacus TPN Calculation Software is designed and intended to allow the ordering of electrolytes in only one of two ways: as a salt (such as calcium gluconate 10%) or as an elemental ion (such as 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 problem associated with mix-ups related to salt-based or ion-based ordering of electrolytes is not exclusive to calcium gluconate.

Affected catalogue numbers include:

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

BACKGROUND: The Abacus TPN Calculating Software is an FDA Class I Laboratory Information Management System (LIMS) Windows-based program used in ordering total parenteral nutrition. This is a classification of the recall initiated in 2009. As of this posting, over 90% of Abacus users have made corrective actions.

The Abacus TPN Calculation Software was manufactured and distributed from August 7, 2006 through April 15, 2009.

RECOMMENDATION: On January 23, 2009, Baxa Corporation sent its customers a “Safety Alert” letter. Customers were instructed 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/25/2012 - Recall Notice - FDA]

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