Medical device manufacturer, Terumo Cardiovascular Systems Corporation (Terumo CVS), has issued a field safety notice concerning Sarns Soft-Flow Aortic Cannulae and Sarns Venous Return Cannulae. The details of the affected products are as follows:
During an in-process inspection, Terumo CVS identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns Soft-Flow Aortic Cannulae and Sarns Venous Return Cannulae.
The presence of loose fiber particulate on the surface or inside of the cannulae tubing may be difficult for users to detect. If loose fiber particulate is present, it could be deposited in the patient's vascular system resulting in varying degrees of patient harm depending on the size of the dislodged material, the location in which it is deposited, and the condition of the patient. Potential outcomes include particulate embolism or an inflammatory response which can create clot, ischemia, or tissue death.
Terumo CVS has not received any reports of loose particulate from customers and there are no reported injuries from the observed defect.
The manufacturer advises users to stop using Sarns Soft-Flow cannulae and Sarns Venous Return cannulae from the affected lots and return all unused affected products to them.
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 October 2013