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FDA 510(k) for CADD-Solis VIP System

Manufacturing Group | February 13, 2013

Designed for home care, new Smiths Medical Smart infusion system revolutionizes medication error reduction in the U.S.

FDA 510(k) for CADD-Solis VIP System

Officials from Smiths Medical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to launch its CADD-Solis VIP ambulatory infusion system with CADD-Solis medication safety software.

“Our CADD infusion systems have a long history of providing reliable and safe infusion delivery for home care patients,” says Srini Seshadri, president,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.”

The new CADD-Solis VIP (variable infusion profile) system is a multi-therapy infusion platform that includes a Smart infusion pump, medication safety software, and dedicated medication cassette reservoirs that attach to the pump. Smart infusion systems are equipped with medication error-prevention software that alerts operators or interrupts the infusion process when a pump setting is programmed outside of preconfigured limits. Smart pumps are designed to recognize prescription errors, dose misinterpretations, and keypad programming errors.*

The CADD-Solis VIP 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.

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

CADD-Solis VIP Ambulatory Infusion System Components:

CADD-Solis VIP Ambulatory Infusion Pump – a versatile pump for multiple therapies including TPN, Intermittent, Continuous, PCA and Step. The large, therapy-specific color screens 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.

CADD-Solis VIP Medication Safety Software - Administrator – designed to help reduce the risk of medication delivery errors, the Windows-based PC Administrator software allows home care pharmacists to enter and store custom therapy-based protocols, drug names, concentrations and dosing limits for standardized programming downloads to CADD-Solis VIP pumps.

CADD Medication Cassette Reservoirs and Administration Sets – exclusive CADD reservoirs and sets contain or connect to medication and fit securely onto CADD-Solis VIP pumps for increased medication security. The pump with reservoirs can fit easily into a pouch so patients can be mobile during therapy.

*Joint Commission Accreditation Manual for Home Care

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