by
Barbara Kram, Editor | December 26, 2006
Baxter received conditional FDA
approval for infusion pump plan
DEERFIELD, Ill. – Baxter Healthcare Corporation has received conditional approval for the COLLEAGUE infusion pump corrective action plan from the U.S. Food and Drug Administration (FDA) and that it has submitted an updated 510(k) pre-market notification filing with FDA. The company anticipates receiving the FDA's response to the notification within 90 days. Baxter plans to begin deployment of the corrective actions in the U.S. following FDA's final approval of the corrective action plan, which is conditioned upon successful 510(k) clearance.
"Reaching these milestones with the COLLEAGUE infusion pump reflects our commitment to resolving reliability and user interface issues associated with these critical devices and restoring our customers' confidence by delivering high quality, innovative infusion technologies," said Robert L. Parkinson, Jr., Baxter's chairman and chief executive officer. "We appreciate our customers'
patience as we've worked to resolve these issues and we look forward to deploying our corrective actions upon receiving 510(k) clearance."
Ad Statistics
Times Displayed: 19090
Times Visited: 362 Stay up to date with the latest training to fix, troubleshoot, and maintain your critical care devices. GE HealthCare offers multiple training formats to empower teams and expand knowledge, saving you time and money
Pumps currently in the market continue to be safe to use when operated according to the user manual and instructions contained in previous customer
communications. Currently, more than 200,000 COLLEAGUE infusion pumps are in use in U.S. hospitals and over 50,000 are used abroad.
Deployment of COLLEAGUE pump modifications outside the U.S. is nearly complete, with 50,000 pumps in 49 countries upgraded. To date, 29 countries have fully completed deployment and COLLEAGUE pump sales have resumed in 37 countries.
In June 2006, Baxter and FDA reached agreement in the form of a consent decree on steps Baxter must take to resume sales of new COLLEAGUE infusion pumps in the U.S. The agreement resolved a court action by the FDA that began with a seizure of COLLEAGUE pumps in Baxter's northern Illinois warehouses in October 2005, which followed field corrective action notices issued by Baxter about design and user interface issues. Issues identified in the field corrective actions are addressed in Baxter's comprehensive correction action plan and new 510(k) submission.
