Recall of Avea Ventilator by CareFusion for Potential Malfunction
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
CareFusion, a BD company, issued a global voluntary recall on April 21, 2015, for AVEA ventilators. The AVEA ventilator-specific 5 psi pressure transducer may develop a failure mode over a period of time, where the ventilator stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia. The recall was designated Class I by the FDA because there is a reasonable probability the ventilator will cause serious adverse health consequences or death. As of yet, no adverse event reports have been received related to this issue.
The global recall involves AVEA ventilators manufactured, serviced and distributed from July 1, 2011 to March 15, 2015. The ventilators are used in hospitals and health care facilities to assist in breathing for newborn through adult patients. If an AVEA ventilator exhibits a sustained Extended High Ppeak or Circuit Occlusion alarm followed by the opening of the safety valve that cannot be resolved by restarting the ventilator, immediately remove the ventilator and provide alternate ventilation. Alternate ventilation support is immediately required to reduce the potential of hypoxemia or hypercapnia.