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www.fdanews.com/articles/68830-baxter-receives-510-k-for-colleague-cx-infusion-pump

Baxter Receives 510(k) for Colleague CX Infusion Pump

February 16, 2005

Baxter Healthcare has received 510(k) clearance from the FDA to market a wireless pump connectivity interface that enables hospitals to connect Baxter's Colleague CX infusion pump to its Patient Care System.

The wireless connectivity system allows healthcare providers to capture real-time patient information when administering medication using the Colleague CX infusion pump, as well as monitor the status of these infusions via a handheld computer. The wireless connectivity interface also enables healthcare providers to review pharmacy-entered prescription information to programmed pump settings at the bedside to ensure the appropriate administration of infusions.

With the new wireless connectivity interface, Baxter's Patient Care System helps clinicians track and verify the administration of infusions. The clinical study will begin in the second half of 2005. Availability of this system to other hospitals, including the introduction of the new wireless connectivity interface, is planned for late 2005, following completion of the clinical study.