Disposable Paediatric ventilation circuits manufactured by Draeger Medical up to March 2016 may leak at the check valve. This puts children at risk of re-breathing exhaled gases, and has triggered MHRA intervention.
Since it has been discovered, Draeger Medical has issued a notice to all those who have, and still use, the device that requires them to identify and quarantine the affected circuits and to return them to Draeger Medical for replacement.
If the circuits have already been disposed of, Draeger Medical still needs to be informed in order to send a replacement. Draeger Medical are to be contacted to acknowledge receipt of the FSN even if you do not have the defected device in stock.
If no alternatives are available, Draeger Medical recommends carrying out a risk assessment in guidance with the FSN. All healthcare workers who use the devices are expected to carry out these actions between 17th of August 2016 and 3rd October 2016, and a suggested distribution list can be found on the Gov.uk website.
First published by Admin on August 16, 2016
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