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:

• Sarns Soft-Flow Aortic Cannulae without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long : catalogue number 5762, lot number 0677300, and date of distribution from 2 August 2012 through 7 August 2012
• Sarns Soft-Flow Aortic Cannulae without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 cm) long: catalogue number 5798, lot number 0677301 and date of distribution from 13 September 2012 through 17 September 2012
• Sarns Soft-Flow Aortic Cannulae without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long: catalogue number 5841, lot number 0677302, and date of distribution from 26 October 2012 through 14 February 2013
• Sarns Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long: catalogue number 9473, lot number 0689812, and date of distribution from 16 November 2012 through 4 January 2013

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