Baxter Gains FDA 510(k) Clearance for Next Generation Infusion Pump

May 26, 2014

May 26, 2014

Global healthcare leader, Baxter, recently gained 510(k) clearance from the Food and Drug Administration (FDA) to market its next generation SIGMA Spectrum Infusion System, a compact electronic device integrally designed for the safe and accurate delivery of fluids and intravenous (IV) medications.

Biomed Monthly – May 2014Redefining smart technology through its advanced safety features, the SIGMA IV pump is armed with the Master Drug Library (MDL) editor software that allows the pharmacy to create and keep customized in-house archives of prescribed and clinically current dosing parameters for all types of infusions.

This clinical breakthrough is primarily aimed at minimizing the occurrence of errors in programming IV drug infusions, which could pose threats to the life of a patient.

The IV pumps, which are scheduled to be released this summer, are also equipped with dose error reduction software (DERS) and wireless connectivity feature that streamlines the data integration into a facility’s electronic medical record (EMR) system. Continuous Quality Improvement (CQI) reports containing updates on infusion data and IV programming inaccuracies, among other information, are also readily available in the SIGMA gateway server to provide pharmacists, clinicians, as well as safety and risk managers with easy data accessibility within the existing drug libraries.

Included among its host of features is its reengineered asset-tracking capability, which would make it easier for healthcare providers to locate, manage, and deploy SIGMA Spectrum inventory for a secured and seamless dispersal of hospital assets. The predecessor of this new SIGMA infusion pump system has been listed among the Top 20 “Best in KLAS: Medical Equipment & Infrastructure for Smart Pumps – large volume pumps (LVP) category in the past three years.

To ensure the safety delivery, dosage precision, and workflow efficiency in the delivery of IV medications, fluids, blood, and blood components, it is critical for healthcare providers to employ no less than medical-grade, top-of-the-line infusion pump systems.

tAIV offers an extensive line of quality replacement parts and expert repair services for Baxter and other industry-leading IV pump manufacturers. Interested parties are encouraged to visit today and learn more about AIV’s infusion pump parts and services.

About the Author

Laura Collier

Laura Collier

Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.

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