FDA Clears New Plasma Protocol Software for Fenwal Alyx® System
Includes Expanded Two-Way Data Communication Supporting Electronic
November 19, 2013
LAKE ZURICH, Ill. – November 19, 2013—Fenwal, Inc., a Fresenius Kabi company, announced today it has received FDA 510(k) clearance for the Alyx® system software version 3.1. The new software gives the Alyx system a protocol for closed system plasma collection and expanded data management capabilities. The Alyx system now includes three procedures to help customers meet their collections needs: two units of red blood cells, one unit of red blood cells with plasma, and plasma alone.
The Alyx system is used worldwide to collect life-saving blood components for patient transfusion. Plasma collected on the Alyx system can be processed as Fresh Frozen Plasma (FFP), Plasma Frozen within 24 hours of collection (PF24) or Plasma Frozen within 24 hours of collection held at Room Temperature for 24 hours (PF24RT24).
"Alyx is a mobile, easy-to-use blood component collection system," said Dean Gregory, president, Medical Devices, for Fresenius Kabi North America. "With this latest clearance, Alyx can now be used to collect up to 825mL of plasma from a single donor, helping blood centers meet the growing hospital demand for plasma. This is the latest of several regulatory clearances for Fenwal products since becoming part of Fresenius Kabi and each is an example of our commitment to advance transfusion medicine."
The new Alyx system software supports remote procedure setup and paperless documentation when used with the Fenwal DXT® Relay data exchange software and a blood center's blood establishment computer system (BECS). With remote procedure setup, donor registration information may be entered remotely into an Alyx instrument. This helps assure data accuracy, documentation compliance, and streamlines processes.
The DXT® Relay software also provides blood center professionals with easy-to-read, on-demand reports that consolidate procedure data from multiple Alyx systems in different locations. The reports track performance indicators and may be used to identify opportunities for operational improvement and training. The DXT® Relay software was built with open architecture so it is integrated seamlessly with existing blood center systems. Once integrated with a center's BECS, DXT Relay can provide data that will meet regulatory requirements for paperless documentation.
Plasma is the liquid portion of blood that contains valuable proteins used to treat burn victims, bleeding disorders, human immune deficiencies and other chronic or genetic disorders. Unlike other blood components, which are stored at room temperature or refrigerated, plasma is frozen and thawed prior to fractionation or transfusion.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com) is a leading global health care company that focuses on pharmaceuticals and medical devices used to care for critically and chronically ill patients inside and outside the hospital. Fresenius Kabi products include intravenous specialty and generic medicines, infusion therapies, clinical nutrition and related medical devices. Within transfusion technologies, Fresenius Kabi offers products for whole blood collection and processing as well as for transfusion medicine and cell therapies. The company's roots go back more than 100 years to the founding of its parent company, Fresenius SE, in Bad Homburg, Germany, where the company is headquartered today.
Acquired by Fresenius Kabi in December 2012, Fenwal (www.fenwalinc.com) is focused on improving transfusion medicine through expertise in blood separation, collection, filtration, storage and transfusion. Fenwal offers a broad range of products and services for the automated and manual collection of blood and blood components.