July 20, 2012
CareFusion EnVe Ventilators: Class I Recall - Leak In Patient Breathing Circuit or System
AUDIENCE: Critical Care Medicine, Risk Manager
ISSUE: FDA notified healthcare professionals of a Class I Recall of CareFusion EnVe Ventilators manufactured from December, 2010 through January, 2012 and distributed from December, 2010 through May, 2012. A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously. The device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised. This product may cause serious adverse health consequences, including death.
BACKGROUND: The CareFusion EnVe ventilator is intended for continuous breathing support for the care of newborns through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care facilities. The firm sent an Urgent Product Recall letter to their customers.
RECOMMENDATION: If ventilation resumes after an intermittent leak and the audible alarm stops, the firm directs users to clear the alarm indicator on the ventilator display by entering the Alarm Messages tab and pushing the alarm reset to clear the display. If the ventilator has a continuous leak and normal ventilation does not resume, the firm directs users to provide an alternate method of ventilation to the patient. The firm instructs users to constantly monitor ventilator-dependent patients to ensure that if a malfunction occurs, alternate ventilation can be provided.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at: