The FDA has issued a Class I recall of leaky breathing tubes that compromise the delivery of ventilation.
The agency is recalling CareFusion EnVe Ventilators made from December 2010 to January 2012, and distributed through May 2012.
It warns that a leak may occur in the patient breathing circuit that results in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously.
This could result in serious adverse health consequences, including death, FDA said.
Both audible and visual alarms on the device will sound in order to notify healthcare teams that ventilation delivery may be compromised, according to the FDA.
If ventilation resumes after an intermittent leak and the audible alarm stops, the company said users should clear the alarm indicator on the ventilator display.
If the ventilator has a continuous leak and normal ventilation doesn’t resume, users should provide an alternate method of ventilation, CareFusion instructs.
The company added that clinicians should constantly monitor their patients who are on ventilators to make sure that if a malfunction occurs, they can provide alternate ventilation quickly.
The tubes are intended for continuous breathing support for all ages, from newborns through adult patients who need mechanical ventilation.
CareFusion sent urgent product recall letter to its customers, and FDA urges clinicians to report adverse events to FDA’s adverse events reporting program, MedWatch.
Earlier this month, the FDA issued a Class I recall of the CareFusion AirLife Infant Breathing Circuit. The device may develop a crack in the Y-adapter, which can reduce the amount of air circulating through the closed system to the patient, according to the company.
Source: Kristina Fiore, Staff Writer, MedPage Today. Published: July 21, 2012