The Saudi Food and Drug Authority would like to warn all healthcare practitioners within healthcare facilities from using Breathing Circuits used with Life Pulse High-Frequency Ventilators manufactured by Bunnell
التاريخ:
2013-01-27
The Saudi Food and Drug Authority would like to warn all healthcare practitioners from using some affected lot ( attached ) of Breathing Circuits used with the Life Pulse High-Frequency Ventilator manufactured by Bunnell.
SFDA has become aware through the international regulatory resources, that the heater wire insulation of the breathing circuit - Disposable Patient Circuits- manufactured by Bunnell- can melt, which may cause a shortage that creates sparks and smoke in the circuit near the humidifier cartridge , leading to potential adverse events of burns , injuries, lung infections or low oxygen levels in the patient’s blood – god forbid -
Saudi Food and Drug Authority encourages that all healthcare practitioners to adhere to the following :
- Identify any affected product in your inventory and contact Saudi Food and Drug Authority .
- If you choose to use the affected product, Bunnell recommends that you perform the following actions to reduce the likelihood of this problem occurring :
1- Visually inspect the circuit and the internal heating wire for thermal damage every 30-60 min (e.g., sections of exposed wire without insulation, melting, or substantial discoloration). In particular, examine the red wires near the humidification chamber.
2- Replace the circuit if a "Circuit Low Temp" alarm unexpectedly activates and the low temperature condition is not resolved within 5 min after following appropriate troubleshooting as described in the operator's manual.
3- Replace the breathing circuit if displayed temperature is noted to be below the set temperature for >5 min.
Affected lot No’s |
Catalog No. 937; Lot Nos.: 12C092, 12C102, 12C115, 12C125, 12C136, 12D159, 12D172, 12D189, 12E204, 12E211, 12E224, 12F241, 12F254, 12F271, 12G279, 12G290, 12G307, 12G321, 12H330, 12H349, 12I362, 12I371 |
Saudi Food and Drug Authority encourages all to report any adverse event associated with medical devices through the National Center for Medical Devices Reporting :
for more information please visit the Saudi Food and Drug Authority website :
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