Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning ABACUS Total Parenteral Nutrition (TPN) Calculation Software with software version 3.1, 3.0, 2.1, and 2.0 manufactured by Baxter. The affected code numbers are 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169 and the affected devices were manufactured from 17 May 2006 through 28 May 2013 and distributed from 17 May 2006 through 17 March 2014.

ABACUS 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.

Due to software failures, the manufacturer 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.

The manufacturer directed customers to follow safe compounding practices, and contact them to ensure that the ABACUS software is configured correctly.

The manufacturer is removing the user's permission to edit the TPN order template configuration. Customers with a software version earlier than 3.1 will have software version 3.1 installed that addresses the issues in the recall. In addition, the manufacturer will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers' facilities.

For details, please refer to the following FDA websites:

• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398509.htm
• http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm398428.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 May 2014