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Devices Drug Delivery FDA

 News Release - September 26, 2011

Smiths Medical Receives 510(k) U.S. FDA Clearance for Wireless Version of the Medfusion(R) 4000 Syringe Infusion System

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- Smiths Medical, a leading global medical device manufacturer, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Medfusion® 4000 wireless syringe infusion pump with the PharmGuard® infusion management software suite. The new customizable system, which helps prevent medication errors, will allow health care providers to send and receive medication delivery information more efficiently.

“The Medfusion® 4000 wireless pump represents the next-generation advancement of the popular Medfusion® 3500 syringe infusion pump, which is widely recognized for its accurate medication delivery to patients in critical care units, including neonatal and pediatric intensive care,” said Tommy Johns, Vice President, Global Product Management. “Our customers have been looking forward to a wireless Medfusion® syringe pump system, and we are excited to bring this new system to market and provide customers with the convenience of wireless transfer of infusion information using their Medfusion® and PharmGuard® systems.”

Hospitals today are looking to improve patient outcomes and clinical care; however, clinicians need the data in order to make these improvements. The Medfusion® 4000 system with wireless connectivity capability allows hospitals to capture many types of infusion data. The PharmGuard® infusion management software suite allows for simple, easy reporting of this data for evidence-based practice improvements. Having a wireless system to update drug libraries on pumps improves both patient safety as well as clinical care by allowing quick and easy wireless update of pumps.

Medfusion® 4000 Pump and PharmGuard® Infusion Management Software Suite Components:

Medfusion® 4000 Syringe Infusion Pump with PharmGuard® Medication Safety Software – a Smart infusion pump that now has wireless (802.11b/g) and wired Ethernet connectivity for efficient drug library, syringe and firmware management, eliminating the need to physically search for pumps and manually update them.

PharmGuard® Toolbox Medication Safety Software – PC software that allows pharmacists to develop drug libraries according to hospital-defined medication dosing best practices and then deploy them to Medfusion® 4000 pumps.

PharmGuard® Server Software – a scalable and upgradeable web-based application that enables the wireless collection, management, and Continuous Quality Improvement (CQI) reporting of patient infusion data to track trends in compliance with medication dosing and clinical best practices.

SureLink™ Remote Support Software – an agent that runs in the background on a hospital’s Windows®-based workstation or server and allows Smiths Medical Customer Support specialists to monitor devices and software, diagnose problems, provide software installation and upgrades, and supply remote support of Smiths Medical products.

Smiths Medical has already launched the Medfusion® 4000 syringe pump with PharmGuard® software in Canada and other markets outside the United States.

About Smiths Medical

Smiths Medical is a leading supplier of specialized medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. It is part of Smiths Group, a global leader in applying advanced technologies for markets in threat and contraband detection, energy, medical devices, communications and engineered components. Smiths Group employs around 22,000 people in more than 50 countries.

Source: Smiths Medical

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