Medical device manufacturer, Terumo Cardiovascular Systems Corporation, has issued a medical device safety alert concerning Sarns Soft-Flow Aortic Cannulae. Affected catalogue numbers are 5762, 5768, 5774, 5841, 5843, 5845, 5847, 7071, 7072.
During in-house inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of excess plastic material, or flash, on the tip of the Sarns Soft-Flow Aortic Cannula. The flash has the potential to detach. Terumo CVS' investigation revealed that:
Terumo CVS is advising users to discontinue use and return all affected cannulae in inventory. It is because the presence of plastic flash on the cannula tip may or may not be visually detected by users. If plastic flash material is present, there is the potential for it to become dislodged and 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 inflammatory response which can create clot, ischemia, or tissue death.
According to the local supplier, the affected products have not been distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 24 December 2012