The Australia Therapeutic Goods Administration (TGA) has issued a medical device safety alert concerning HomeChoice Pro Automated Peritoneal Dialysis (APD) System manufactured by Baxter Healthcare. Products with product code R5C8320 and the serial numbers 300905, 300882, 300928, 300889 are affected.
There is a potential issue with the occluder assembly of HomeChoice Pro devices. The blade of the occluder assembly is covered with a rubber boot. The occluder blade clamps the solution lines if a power failure occurs or when the cycler is off. This prevents uncontrolled solution delivery to the patient.
An occluder failure will cause an unrecoverable Slow Flow/No Flow alarm or an unrecoverable System Error. The device will fail in a safe position and prevent solution from being delivered to the patient.
Baxter is informing the affected hospitals of the issue. Hospitals will either notify affected patients or Baxter will contact patients via Homecare and arrange to swap the affected machines. Baxter is also advising patients to perform manual peritoneal dialysis to continue therapy if there is an unrecoverable failure.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01117-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 November 2013