| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00626-1 |
| Product Name/Description |
Aquarius GEF08200 Device, V4 Software |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
Baxter is recalling this device due to the ability to override the Total Fluid Balance Alarm which could potentially lead to hypovolaemia or hypervolaemia. A software update was initially proposed to correct the issue for models GEF08200 and GEF09600, however as the software update was found to incompatible with model GEF08200, Baxter determined that there was no permanent solution available for this model. |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospitals are requested to provide Baxter with details of the units remaining in use. On receipt of this notification Baxter will organise for the recovery of the device. The Aquarius GEF08200 with V4 software can continue to be used until replacement devices are sourced provided the work around identified in the device Warning Label is followed. The warning label contains the following information:
WARNING
Repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. Beware this can cause serious patient injury. You need to identify the cause of the alarm and correct the fluid rate if necessary. |
| Contact Information |
02 9848 1111 - Baxter Healthcare |