Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms
Audience: Pharmacy, Nursing, Risk Manager
Including ABACUS Total Parenteral Nutrition Calculation Software, v3.1, v3.0, v2.1, and v2.0.
ISSUE: FDA notified health professionals of a Class I Recall due to software failures when using ABACUS TPN calculation software. If any of these failures were to occur, patients may be at risk for toxic or overdose symptoms. 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 affected software was manufactured from May 17, 2006 through May 28, 2013 and distributed from May 17, 2006 through March 17, 2014. Affected product codes can be found in the FDA Recall Notice.
BACKGROUND: 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.
RECOMMENDATION: On April 21, 2014, Baxter sent an Urgent Device Correction letter to all affected customers. Baxter’s letter directed customers to contact Baxter to ensure that the ABACUS software is configured correctly. 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, Baxter Support Services will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers’ facilities.
Baxter also requested that its customers take specific actions, which can be found in the FDA Recall Notice.
Health care professionals: For questions about the actions to be taken, contact Baxter Technical Support at 1-800-678-2292, Monday through Friday, 6 am - 5 pm, Mountain Time or by email at COtechsupport@baxter.com. For questions about the recall, contact Baxter at 303-617-2242.
Patients having this procedure at home: For questions about this recall, contact your home health care agency or doctor.
[05/22/2014 - Recall Notice - FDA]