| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00339-1 |
| Product Name/Description |
Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)
ARTG Number: 93955 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Aisys CS2 anaesthesia devices and upgraded Aisys anaesthesia devices deliver a momentary, self-correcting increase of the anaesthetic agent, affecting the inhaled and exhaled concentrations for a short time, upon either of the following setting changes:
· A fresh gas setting change from 95%-25% oxygen to only air (21% oxygen).
· Any total flow setting change while using 21% oxygen (air only).
The momentary bolus of anaesthetic agent will not occur with nitrous oxide as the carrier (balance) gas or if the oxygen concentration is set above 21% (air only). Delivery of this momentary bolus of anaesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable paediatric patients when 21% oxygen (air only) is used. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising if possible, an alternative device should be used for paediatric patients until this safety issue is resolved. If 21% O2 in fresh gas is used, any adjustment to the fresh gas flow will deliver a bolus of inhaled anaesthetic agent, however the effects are short in duration. If the issue occurs, the device will automatically recover and return to steady state. Depending on your system configuration, one or both of these alarms could trigger if this issue occurs:
-Clinician adjustable “Fi XXX High” alarm (XXX denotes the specific agent)
-Alarm if respiratory gas monitoring is not present.
GE will be providing a correction as a permanent fix. This action has been closed-out on 20/02/2017. |
| Contact Information |
1800 659 465 - GE National Call Centre |