| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00093-1 |
| Product Name/Description |
AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines
ARTG Number: 112135 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Gambro has received complaints related to a technical error in the AK 200S nocturnal home haemodialysis machines, which will stop all the pumps and close the venous clamp. This has led to 3 cases of 400mL of blood loss and a 2 day treatment delay. A further 21 reported cases resulted in a technical error and a minor treatment delay.
One section in the Operator’s Manuals for the AK 200 S and the AK 200 ULTRA S instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. Restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss for the patient.
No Deaths or injury have been reported as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
An addendum to the Instructions for Use is to be communicated to customers. This action has been closed-out on 03/08/2016. |
| Contact Information |
02 8852 3700 - Gambro Pty Ltd |