Australian Therapeutic Goods Administration (TGA), has issued a medical device safety alert concerning D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors, manufactured by GE Healthcare.
The affected devices are identified as follow:-
The manufacturer has recently become aware of a potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Occlusion of specific lots of D-Fend/D-Fend+ water traps could occur immediately after replacement. This water trap occlusion could cause a loss of respiratory airway gas monitoring. When this issue is detected the connected monitoring device will issue an audio alarm and display "low gas sample flow", "replace water trap" or "sampling line blocked" warning messages. Unattended or prolonged warnings could lead to an adverse clinical situation if the CO2 value would rapidly change in certain clinical conditions
Affected users are advised to collect and dispose of the affected water traps. The manufacturer will replace all affected products.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00366-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 April 2015