Baxter Abacus TPN Calculation Software Recalled (Class I) Because Software Errors May Cause Toxic/Overdose Symptoms
The FDA informs pharmacy, nursing personnel and risk managers that Baxter Abacus TPN Calculation Software is recalled because software errors may cause toxic/overdose symptoms.
Background of Baxter Abacus TPN Calculation Software
ABACUS Total Parenteral Nutrition (TPN) Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas for the nutritional needs of patients who cannot eat or drink by mouth.
FDA Alert on Baxter Abacus TPN Calculation Software
FDA’s reason for the recall is that software failures can put patients at risk for toxic or overdose symptoms including fatigue, dizziness, vomiting, or nausea. More severe symptoms include cardiac arrhythmia, pulmonary edema, congestive heart failure and seizures. The symptoms may be life-threatening for high risk patients.
The affected products include: ABACUS Total Parenteral Nutrition Calculation Software, v3.1, v3.0, v2.1, and v2.0.
The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.
FDA Recommendation on Baxter Abacus TPN Calculation Software
“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 [email protected] 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.”
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