Baxter’s ABACUS Total Parenteral Nutrition (TPN) Calculation Software was subject to a Class I recall. The firm received two reports in which the device 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.
- 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 TPN is meant to serve.
ABACUS Total Parenteral Nutrition (TPN) Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas. TPN is used to meet the nutritional needs of patients who cannot eat or drink by mouth and is used in the hospital or in the home by a licensed health care professional. Other uses of ABACUS include: non-TPN volumes administered to patients on TPN therapy, epidural calculations, dilutions from a concentrated ingredient, combinations of multiple ingredients, and fractional doses from larger volumes.
Versions 3.1, v3.0, v2.1, and v2.0 were recalled. The software was marketed by Baxter Corporation Englewood, manufactured from May 17, 2006, through May 28, 2013, and distributed from May 17, 2006, through March 17, 2014.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication