| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00860-1 |
| Product Name/Description |
Ultrafilter U9000 (Used on Gambro Haemodialysis Delivery Systems.)
ARTG Number: 131741 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Gambro Pty Ltd is advising users of the potential for external fluid leakage from the Ultrafilter U9000 due to multiple disinfections using a sodium carbonate-based solution. Intensive use of sodium carbonate based disinfection programs over several months may cause degradation of the ultrafilter housing leading to an external fluid leakage at the position of the welding seal between the filter housing and the header cap. If the leakage is slow developing, there is a remote probability that it will not be noticed until the dialysis treatment has started. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If a leakage is observed during treatment, the users are advised to immediately stop the treatment and change the U9000 Ultrafilter to avoid excessive fluid removal from the patient.
Gambro is advising that the use of sodium carbonate-based disinfection programs has been broadly validated for the U9000 Ultrafilter. However, to minimise the risk of an external fluid leak, Gambro recommends adhering to the following instructions, when using sodium carbonate based disinfection programs:
1. Do not exceed the recommended disinfectant concentration given in the Operator’s Manual.
2. Do not use more than eight sodium carbonate disinfection cycles over the lifetime of the U9000.
3. Do not use sodium carbonate disinfection cycles more than once a week.
4. Include daily disinfection with citric acid in the disinfection protocol.
5. Avoid periods of machine inactivity (e.g. weekend storage) directly after disinfection with sodium carbonate based agents.
6. The recommended process of combined “Heat + CleanCart-A” disinfection shall be followed by a “Heat + CleanCart-C” disinfection on the same day and ideally be performed in the middle of the working week. This action has been closed-out on 03/06/2016. |
| Contact Information |
02 8852 3700 - Gambro Pty Ltd |