FDA slaps Bunnell Inc.’s Life Pulse High-Frequency Ventilator Patient Circuits with Class I status over concerns that the heater wire may fail when treating ventilating critically ill infants.
Salt Lake City, Utah-based medical maker Bunnell Inc. this month launched a nationwide recall of its Life Pulse High-Frequency Ventilator Patient Circuits after receiving failure reports among certain lots.
Bunnell received reports of failure for 12 out of 5,743 circuits, which are used for ventilating critically ill infants with pulmonary interstitial emphysema and those with respiratory distress syndrome.
The circuits provides a conduit for the humidification, warming, and temperature monitoring of the pressurized gas, according to an FDA notice.
The recalled devices' heater wire insulation can melt and release smoke near a patient's humidifier cartridge, which may cause serious adverse consequences, including death, according to FDA.
The reports received thus far suggest an occurrence rate of 0.21%, and no injuries or deaths associated with the fractured devices have yet been reported, Bunnell said.
The recalled patient circuit lot numbers are:
|12C092 12E211 12H330
12C102 12E224 12H349
12C115 12F241 2I362
12C125 12F254 12I371
12C136 12F271 12I397
12D159 12G279 12J413
12D172 12G290 12J430
12D189 12G307 12J448
12E204 12G321 12K457
If customers want to continue use of the High Frequency "Jet" Ventilator system, including the Patient Circuit, they must send a Certificate of Medical Necessity to Bunnell, the company said.
When using the system, customers should visually inspect both the circuit and the internal heating wire every 30 to 60 minutes for thermal damage, Bunnell added.
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