Class I Baxter Corporation Englewood ABACUS

Company: Baxter Corporation Englewood
Date of Enforcement Report:4/2/2014
Class I:

PRODUCT

Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 – Software Errors May Cause Toxic or Overdose Symptoms.
ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows – based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations. Recall Number Z-1566-2014

REASON
The firm received 2 reports in which the device has malfunctioned.

Due to software failures, the firm has identified the following potential issues when using ABACUS TPN calculation software:

ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders.
ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution.
All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly; and
All software versions of ABACUS may display an inaccurate estimation for calcium and phosphate precipitation in certain circumstances where multiple ingredients provide calcium.
If any of these failures were to occur, patients may be at risk for toxic or overdose symptoms. The symptoms are varied and depend on the type of software failure and composition of the fluid being compounded. Symptoms may be non-specific and include nausea, vomiting, dizziness or fatigue. Some more severe symptoms include a problem with the rate or rhythm of the heartbeat (cardiac arrhythmia), an abnormal buildup of fluid in the air sacs of the lungs, which leads to shortness of breath (pulmonary edema), congestive heart failure and seizures. A fatal outcome is possible, especially with the high risk population.

RECALLING FIRM/MANUFACTURER
Baxter Corporation Englewood, Englewood, CO on 4/2/14. Voluntary recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2034

DISTRIBUTION
Nationwide and Internationally

FDA District: Denver District Office

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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