A Medical Device Daily
Baxter Healthcare (Deerfield, Illinois) reported receiving conditional approval for the COLLEAGUE infusion pump corrective action plan from the FDA and said that it has submitted to the agency an updated 510(k) premarket notification filing.
The company said it anticipates receiving the FDA’s response to the notification within 90 days and will begin deployment of the corrective actions in the U.S. following FDA’s approval of the corrective plan, which is conditioned upon 510(k) clearance.
The pump has been associated with a handful of deaths and injuries. In September of 2005, it said excessive discharge had caused battery damage, which was associated with four deaths and 10 injuries (Medical Device Daily, Sept. 2005).
In this week’s notice, Baxter said that it had received reports from customers of battery damage due to excessive discharge. These malfunctions, it said, have been associated with four deaths and 10 serious injuries. Company recalls of the pumps have been identified as Class I by the FDA.
“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 Parkinson Jr., CEO and chairman of Baxter.
The company said that pumps currently in the market continue to be safe to use when operated according to the user manual and instructions contained in previous communications. Currently, more than 200,000 COLLEAGUE infusion pumps are in use in U.S. hospitals and over 50,000 are used abroad.
It said that 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, Baxter reached agreement with the agency on a consent decree for 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.
Baxter Healthcare is a subsidiary of Baxter International.