CareFusion's latest malfunction draws FDA's most serious label

CareFusion is warning of a malfunction in its AVEA ventilators.--Courtesy of CareFusion

CareFusion ($CFN) is back in familiar regulatory waters, cautioning customers of a malfunction in one of its ventilators and earning the FDA's most dire warning for the third time this year.

At issue are CareFusion's AVEA ventilators, used to assist patients' breathing. If used at high altitudes on their neonatal setting, the devices can under-report tidal volume, possibly resulting in a higher-than-expected output that puts patients at risk. The issue doesn't affect AVEA's adult or pediatric settings, and it only flares up when units are used more than 5,000 feet above sea level, according to the company. CareFusion isn't asking patients to return the devices but instead working on a software update to correct the problem.

In the meantime, the FDA has labeled the action a Class I recall, reserved for device malfunctions that can lead to serious adverse events including death. The agency is asking patients and physicians to report any adverse events through its MedWatch system.

That makes for CareFusion's third such blemish this year, following two Class I recalls tied to its Alaris line of infusion pumps. In August, the company warned that some of its Alaris PC units shipped with lower voltages than needed, risking a failure of communication between the processor and keyboard. In March, CareFusion warned that using certain Alaris attachments could render the keyboard unresponsive until the pump could be restarted, putting patients in danger.

CareFusion has now been plagued by regulatory woes for years, and the near-constant FDA trouble might be weighing on sales. The company's medical systems revenue slipped 5% to $2.3 billion in the fiscal year ended June 30, dragged down by declines in respiratory technologies and infusion systems. On the whole, CareFusion's sales dipped 1% to $3.6 billion in fiscal 2013.

- read the FDA's statement