UPDATED April 9, 2013, to correct errors.
The U.K.’s Medicines & Healthcare Products Regulatory Agency issued a warning on the Alaris GP infusion pump made by CareFusion (NYSE:CFN), reiterating earlier warnings from this side of the pond late last year.*
In November 2012, 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 at the time.
"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 last year. "This suggests that the Alaris GP Infusion System air-in-line detector provides sufficient protection from embolism."
The UK alert asked healthcare providers to use an air venting filter on infusion pumps for neonates or patients with atrial septal defects, as well as patients who are hooked up to multiple infusion pumps.
CareFusion has faced uphill battles with the Alaris line. In August 2012 the FDA slapped the Alaris model 8100 infusion pump recall with Class I status, determining that a door keypad overlay could lead to a keypad malfunction.
The company also faced regulatory problems in July of 2012 with its AirLife infant breathing device, prompting CareFusion to add $7 million to its "recall reserve."
CFN shares were up 0.3% today to $34.58 apiece as of about 2 p.m.
*Correction, April 9, 2013: This article originally confused CareFusion’s Alaris GP infusion pump with its Alaris 8100, and incorrectly referred to the Alaris GP as an insulin pump. It is an infusion pump. Return to the corrected sentence.