Bunnel Life Pulse High-Frequency Ventilator Patient Circuits have been recalled because the device’s melted insulation can lead to sparking and smoke, the U.S Food & Drug Administration (FDA) just announced.
The agency notified healthcare professionals and their provider organizations that the Bunnell Life Pulse High-Frequency Ventilator has been found to have heater wire insulation that can melt, causing sparking and smoke, close to the humidifier cartridge. This defect can lead to serious adverse consequences, including death.
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.
The recalled patient circuits were distributed after March 19, 2012 through October 2012. Affected lot numbers are
12C092 12E211 12H330
12C102 12E224 12H349
12C115 12F241 12I362
12C125 12F254 12I371
12C136 12F271 12I397
12D159 12G279 12J413
12D172 12G290 12J430
12D189 12G307 12J448
12E204 12G321 12K457
On November 19, 2012, Bunnell sent its customers an Urgent: Medical Device Recall Notification letter by certified mail, which indicated the reason for the recall, the potential risk to health, and actions to be taken by the customer/user. The letter pointed out that while a recall has been issued, the firm is not replacing the defective circuits. The MedWatch Safety Alert, including a link to the Recall Notice, is available here.
All serious adverse events and product quality problems should be reported to the FDA MedWatch program at: www.fda.gov/medwatch/report.htm.