The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning Carestation 620, Carestation 650, and Carestation 650c Anaesthesia systems, manufactured by GE Healthcare.
The manufacturer has recently become aware that an incomplete seal can exist between the CO2 absorber and the breathing circuit CO2 bypass port assembly of the Carestation 600 Series systems. An incomplete seal can allow rebreathing of patient gases that have bypassed the CO2 absorbent material and could result in unintended elevated levels of inspired CO2 (FiCO2), which could lead to hypercarbia. To date, there have been no injuries reported as a result of this issue.
The manufacturer is advising users as an interim solution to increase the flow of fresh gas to reduce the volume of patient gas that is rebreathes if elevated FiCO2 levels are observed. If the FiCO2 levels cannot be adequately reduced with this action, users should consider switching to another anaesthesia delivery device.
The manufacturer is releasing revised parts that minimise the likelihood of incomplete gas flow through the CO2 absorbent canister.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01300-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 October 2017