Medical device manufacturer, Terumo CVS Corporation, has issued an urgent field safety notice concerning Sarns™ Antegrade Cardioplegia Cannula.
The manufacturer is recalling certain lots of the devices as they found a foreign substance on the inner surface of some cannulae tips. Their preliminary investigation revealed that the substance can be dislodged from the cannula surface. Moreover, the substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined; and any unit manufactured within the last three years on the same mold could potentially be affected.
The resulting patient harm would vary from a localized inflammatory response in the coronary vasculature that could result in post-operative myocardial irritability to the creation of an embolus that would disrupt or block coronary blood flow and could result in post-operative myocardial infarction. If particulate escaped the coronary arteries and embolized elsewhere in the vasculature, the results could vary from a localized inflammatory response to organ dysfunction or stroke. There have been no reports of patient injury related to this issue.
According to the local supplier, the affected devices were not distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 14 May 2012