Updated November 15, 2012, at 2:15 p.m. with comment from CareFusion.
CareFusion (NYSE:CFN) issued a new warning over potential issues with its Alaris infusion pumps, a product line already targeted by 2 recalls.
The San Diego-based device maker warned clinics that its Alaris GP Infusion pumps produce air bubbles that are too small to trigger the device’s detection and alarm system, creating a possibility that an air bubble may be transferred to a patient, which could then result in a pulmonary air embolism.
CareFusion discovered the issue through post-market surveillance of the Alaris systems, according to the warning, which was also noted by Hong Kong regulators.
The company could not provide details outside of what was contained in the warning letter, but did confirm that the device is manufactured and sold exclusively outside the U.S., CareFusion spokesman Troy Kirkpatrick told MassDevice.com today.
"CareFusion is not aware of any reports of fatal venous or arterial air embolisms that occurred during the use of the Alaris GP Infusions System having functional air-in-line detectors," the company noted. "This suggests that the Alaris GP Infusion System air-in-line detector provides sufficient protection from embolism."
Nonetheless, CareFusion issued updated instructions for the Alaris systems, asking clinics to use an air venting filter for certain higher-risk patients, such as neonates, and in critical care areas where patients may require multiple parallel infusions.
"The remote but unacceptable potential for a death or serious injury action however suggests that action is justified to prevent further use of Alaris GP infusion systems without users considering additional safety precautions to mitigate the elevated risk," according to the warning letter.
The latest warning comes on the heels of a pair of others for the Alaris systems. In August the FDA slapped CareFusion’s Alaris model 8100 infusion pump recall with Class I status after the agency determined that a door keypad overlay could lead to a keypad malfunction.
Earlier this CareFusion recalled certain lots of its AirLife infant breathing circuits and certain Alaris infusion pumps, in the process adding $7 million to its "recall reserve" for the 2nd quarter.
CFN shares saw a modest slide today, trading 0.5% lower at $26.60 as of about 12:45 p.m.
