Important Safety Alerts

Therapeutic Goods Administration (TGA), Australia, has issued a medical device safety alert concerning 4008 HD Bloodlines [AV/FRES 2008-4008 (F00007119) and AV/FRES 4008 (F00007120)], manufactured by Fresenius Medical Care AG & Co KGaA.

The manufacturer has been made aware of incidents regarding quality, safety and performance of the 4008 HD Bloodlines Tubing. The currently supplied roller clamp may cause customers to experience difficulties in handling that might result in excessive force being used to close the clamp causing the roller part to detach. This may cause infusion of saline solution in the event of incorrect use of the roller clamp, if the second clamp present on the arterial line is also damaged or not closed.

According to the manufacturer, a number of leakages were reported at several locations on the 4008 bloodline tubing systems. Leakages on the bloodlines may cause blood loss into the environment and may lead to air intake into the system. While the air intake is normally detected by the dialysis machine's air detector, a leakage of blood may not be detected.

The affected users are advised to follow the Instructions for Use in each carton box of the HD bloodlines:

• Ensure that all caps and connections are secure;
• Inspect the extracorporeal circuit for leaks during priming phase and treatment, taking corrective measures (e.g. tightening Luer-Lock connection) or exchanging the bloodline as necessary;
• Ensure that no excessive force is applied on the roller clamp on the reinfusion set in order to regulate the flow of fluid through the infusion pathway.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 13 April 2018