Product defect correction: Carestation 750/750c Anesthesia Delivery Systems – O2 mixer failure conditions
ANZCA has become aware that GE Healthcare has issued a product defect correction for Carestation 750/750c Anesthesia Delivery Systems manufactured by Datex-Ohmeda Inc. The defect may occur if the system is used with the optional auxiliary outlets (ACGO (Auxiliary Common Gas Outlet) or Auxiliary O2+AIR), when there is clamping, kinking, blockage or high resistance in the nasal cannula or linear circuit. In these conditions the system will enter a mixer failure state, which will trigger audible and visible alarms and a switch to alternative ventilation with 100% O2. The failure state will not end until system reboot.
Prolonged ventilation with 100% O2 creates a risk of hyperoxia and oxygen toxicity for patients who have a higher sensitivity to oxygen, such as paediatric patients.
GE Healthcare has undertaken to provide software updates and parts replacement (where relevant) to all affected machines by December 2022. Prior to these corrections, interim safety instructions for continued operation of these machines have been issued to affected hospitals by GE Healthcare.
ANZCA advises fellows using affected machines to be sure to access, read and follow the interim safety instructions issued to the hospital.
More information is available from the TGA recall listing for Australia or the Medsafe recall listing for New Zealand.