Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00095-1 |
Product Name/Description |
Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Device
Product Codes: GEF09500
All Citrate Platform 6 Devices
ARTG Number: 189947 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
21/02/2014 |
Responsible Entity |
|
Reason/Issue |
The manufacturer has completed a software solution to prevent the potential risk of fluid overload or fluid loss caused by repetitive clearing of the balance alarm and providing users with updated Instructions For Use (IFU). |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Baxter is notifying their customers of this problem and advising that repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. The cause of fluid balance alarms must be identified and the fluid rate adjusted accordingly. A software update will be provided to correct the issue. This action has been closed-out on 19/02/2016. |
Contact Information |
02 9848 1111 - Baxter Healthcare |