Medical device manufacturer, Baxter, has issued a medical device alert concerning its ArtiSet Blood Tubing Sets (Product Codes: 955075, 955077).
The manufacturer received customer reports of kinked access lines observed in its cartridge sets during haemodialysis treatment. This has the potential to cause delay in therapy, blood circuit clotting as a result of reduced blood flow, and haemolysis.
According to the manufacturer, customers can continue to safely use the affected cartridge sets by inspecting them prior to use as advised in the relevant Instruction For Use. If a kink is identified during inspection, the cartridge set must not be used. If a kink is identified during treatment, therapy must be interrupted, and the set must be replaced to restart therapy.
According to the local supplier, the affected products were distributed in Hong Kong from 1 Feb 2018. It stated that there has been no report of adverse event or product complaint potentially associated with this issue in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 6 January 2021