| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00118-1 |
| Product Name/Description |
AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration 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 |
17/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Edwards Lifesciences (previous legal manufacturer of AQUARIUS devices in the market) initiated a FSCA to address the issue related to the potential risk of fluid overload or fluid loss caused by the repetitive clearing of the balance alarm without solving the balance alarm cause. Field Safety Notices were sent to customers warning users about the potential danger for repetitive clearing of the balance alarm without solving the balance alarm cause.
NIKKISO Europe (manufacturer of AQUARIUS devices) has now completed a software solution to prevent the repeated overriding of the balance alarm by implementing Total Fluid Loss (TFL) management in software 6.02. This product improvement is accompanied by a revised instructions For Use (IFU). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Nikkiso Account Manager will contact the customer shortly to schedule the onsite modification, calibration and training based on availability of the hospital staff as well as devices.
This action has been closed-out on 04/09/2018. |
| Contact Information |
0498 009 677 - Sales and Marketing Manager Nikkiso ANZ |