Australian Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines, manufactured by Gambro.
The manufacturer 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
According to the local supplier, the affected products are distributed in Hong Kong.
For details, please refer to the following TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00093-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 February 2015