| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01415-1 |
| Product Name/Description |
AK 98 Self-Care Haemodialysis machine with software versions 1.1.0 and earlier
Product Code: 115250
Serial Numbers: 11295, 10357, 10359, 10360 &10362
ARTG Number: 112135 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
1/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Two software issues have been identified, as follows.
1. It has been identified that the machine could become stuck in a fluid by-pass state if the operator confirms the air detector alarm during priming. In a fluid bypass state, the fluid path bypasses the dialyzer and no ultrafiltration (UF) or diffusion occurs, leading to an absence of therapy. Thus, the patient may not receive the prescribed therapy when the machine gets stuck in a bypass state.
2. It has been identified that the Ultrafiltration Supervision (UFS) may be put in an (non-functional) idle state, if the functional check of the blood module is delayed and is completed after the functional check of the fluid module. When the UFS is in a non-functional state, the machine may not be able to detect deviations in ultrafiltration during treatment. This could lead to hypovolemia or hypervolemia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Baxter is advising users that a software update will be released early 2016 as a permanent fix. Baxter will contact users to arrange for the upgrade once the new software version is available. In the interim, the following instructions should be followed. 1. Make sure that the blood pump door is closed during the Function Check i.e. before “Green Fluid Path” is reached. 2. Wait to put the blood lines and the dialyser on the machine until the machine has reached Green Fluid Path.
This action has been closed out on the 12/10/2018. |
| Contact Information |
02 9848 1111 - Baxter Healthcare |