The FDA classified the recall of CareFusion‘s (NYSE:CFN) Alaris PC software as Class I, the federal watchdog agency’s most serious recall level denoting the risk of serious injury or death.
The problem occurs with CareFusion’s Alaris 8015 running the 9.12 software version, with affected units displaying communication errors when attached to EtCO2 or SpO2 modules.
The San Diego-based medical device company told clinics to either stop using the 2 module attachments or weigh the risks and benefits of continuing use with the communication error display screen. The company is not requesting customers return the devices and will instead visit care sites to upgrade the software.
According to the FDA recall notice, when the PC unit displays a communication error the infusion will continue normally, but there are problems with key press responses and powering down the device will stop all infusions, which could result in serious injury or death.
It’s the latest in a series of regulatory warnings and recalls for some of the Alaris infusion pump line, designed to electronically control drug and fluid delivery to patients.
The U.K. warned CareFusion on its Alaris GP infusion pump earlier this month. Regulators across the pond requested that healthcare providers use an air venting filter on the pumps for certain patients. The Alaris GP infusion pump was also the subject of FDA warning letters and recalls in 2012.
