FDA Clears Smith Medical’s CADD®-Solis VIP Ambulatory Infusion System

In short

Device company Smiths Medical has announced FDA 510(k) clearance for its CADD®-Solis VIP ambulatory infusion system with CADD™-Solis medication safety software.

Background

Smiths Medical’s new CADD®-Solis VIP (variable infusion profile) system is a versatile, multiple therapy pump for applications including TPN, Intermittent, Continuous, PCA and Step. The company says its device features a large, therapy-specific color screen to help easily differentiate each delivery mode and provide intuitive, easy-to-use navigation. The on-board library holds up to 500 protocols, and pharmacist-defined soft and hard limits provide clinician control and medication safety.

The system includes five delivery modes: Continuous, Intermittent, Taper, PCA (Patient Controlled Analgesia) and Step. This allows the system to be used for a variety of therapies including TPN (Total Parenteral Nutrition), chemotherapy, antibiotics, hydration, pain management, and Intravenous / Subcutaneous Immunoglobulin infusions for adult and pediatric patients.
The pump’s user interface is patient focused and displays therapy information in an easy-to-understand format to help reduce training time. The medication safety software allows clinicians to download therapy information directly from their personal computer into the pump as well as view reports on infusion data and delivery history for quick and easy therapy assessment and continuous quality improvement.

Company comments

“Our CADD® infusion systems have a long history of providing reliable and safe infusion delivery for home care patients,” said Srini Seshadri, President of Smiths Medical. “We are extremely pleased to be able to continue that tradition with a smart, innovative new system that will help home care providers to prevent pump programming errors and improve patient safety. The new CADD®-Solis VIP system provides enhanced safety features and convenience for health care providers who want to provide optimal care for their infusion patients in the home.”

Regulatory status 

The CADD®-Solis VIP system is currently available for sale in Canada, France, Germany, Switzerland, the Netherlands, Australia, the UK, and the Middle East.

Source: Smiths Medical, Inc., Business Wire