Medical device manufacturer, Terumo® Cardiovascular Systems Corporation, has issued a field safety notice on the use of unauthorized cable for Terumo® Advanced Perfusion System 1.
The manufacturer is aware of some users operating a Terumo® Advanced Perfusion System 1 with a modified cable to connect the system to an occluder for the Sarns™ Modular Perfusion System 8000. The cable is not specified for use with Terumo® System 1 and its use in this manner constitutes an off-label use.
The modified cable is not compliant with Terumo® System 1 specifications and its use may result in hazardous conditions such as easy dislodgement from the system base resulting in loss of the occluder's function. It may cause the system to lose electro-magnetic interference protection or create a minor shock hazard in the event of an internal short/failure within the occluder system components.
According to the local supplier, the affected product is not distributed in Hong Kong. If you are in possession of the product, please contact your supplier for necessary actions.