510(k) for infusion pump with master drug library

510(k) for infusion pump with master drug library

Baxter’s next-generation SIGMA Spectrum infusion pump includes increased drug library capacity and device tracking services

May 13, 2014
Manufacturing Group
Contract Manufacturing Design/Engineering Devices/Implants/Equipment Industry/Regulations People/Facilities

Deerfield, Illinois – Baxter International Inc. officials announce receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its next-generation SIGMA Spectrum Infusion Pump with Master Drug Library. Enhancements to the infusion pump include increased capacity of the master drug library, which is safety software that enables a hospital to maintain a customized in-house library of facility-defined dosing parameters for infusions to minimize the likelihood of drug errors during care. In addition, new asset-tracking capabilities will allow hospitals to effectively locate, manage, and deploy SIGMA Spectrum inventory, helping to ensure efficient allocation of hospital assets.

Baxter plans to launch the next-generation SIGMA Spectrum with select healthcare facilities beginning in the summer of 2014.

"Clinicians are looking for integrated systems that are efficient and cost effective, and allow hospital staff to focus on providing quality care for patients," said Brik Eyre, president of Baxter's Hospital Products business. "We are excited to bring the next generation of Baxter's SIGMA Spectrum Infusion Pump with Master Drug Library and its advanced, patient-centered safety technology to the U.S. marketplace."

Infusion pumps are used throughout hospitals and other acute and chronic care settings to deliver fluids and medications that save and sustain lives. Baxter's SIGMA Spectrum Infusion Pump with Master Drug Library provides multiple safety features, including dose error reduction software (DERS) and an automatic default to use of the drug safety library at the initial start of dose programming. It also offers an option for wireless connectivity to integrate data into a hospital's electronic medical record (EMR) system, to facilitate the transfer of data to and from the system for updating drug libraries, and to create continuous quality improvement reports.

Source: Baxter International Inc.