CareFusion EnVe Ventilators Recalled due to Potential Leak In Patient Breathing Circuit or System

Critical Care Medicine and Risk Manager healthcare personnel are informed by the FDA that CareFusion EnVe Ventilators are recalled due to a potential leak in patient breathing circuit or system that can cause serious adverse events, including death.

Background of CareFusion EnVe Ventilators

CareFusion EnVe Ventilators are used for continuous breathing support for the care of patients (from newborns to adults) requiring mechanical ventilation in hospitals and other healthcare facilities.

FDA Alert on CareFusion EnVe Ventilators

FDA’s reason for the recall is that a leak might occur in the patient breathing circuit or system of the CareFusion EnVe ventilators causing the system not to hold the set Positive End Expiratory Pressure (PEEP) value. Healthcare professionals will be notified that ventilation delivery to the patient might be compromised and this can lead to serious adverse events, including death.

The affected CareFusion EnVe Ventilators have manufacture dates from December 2010 to January 2012 and distribution dates from December 2010 to May, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on CareFusion EnVe Ventilators

“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.”

Contacting the FDA to report cases with CareFusion EnVe Ventilators

In case of detection of adverse events or side effects related to the use of CareFusion EnVe Ventilators, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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