December 27, 2012 -- Audience: Risk Manager, Anesthesiology
ISSUE: FDA notified healthcare professionals and their provider organizations that this product has been found to have heater wire insulation that can melt, causing sparking and smoke, close to the humidifier cartridge. This can cause serious adverse consequences, including death.
BACKGROUND: Patient circuits are used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The patient circuit provides a conduit for humidifying, warming, and temperature monitoring of the pressurized gas. The patient circuit is indicated for a seven-day single use. These patient circuits were distributed after March 19, 2012 through October, 2012. Affected lot numbers can be found in the Recall Notice and on Bunnell’s website, www.bunl.com
RECOMMENDATION: On November 19, 2012, Bunnell sent its customers an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter by certified mail. The letter included the reason for recall, the potential risk to health, and actions to be taken by the customer/user. The letter also stated that although this is a recall, the firm is not replacing these circuits at this time.