Terumo Cardiovascular Systems (Terumo CVS) issued an urgent product removal of Level Sensor II Pads. The removal followed an investigation about the reports of Level Sensor II Pads detaching from the surface of the venous reservoir. The affected products are of an older population that is labeled with a manufacture date but not an expiration date. They were shipped between December 28, 2000 and January 1, 2010. The adhesive is intended for use within two years of the date of manufacture, otherwise it may detach.
The detachment of the level sensor pad from the venous reservoir compromises the capabilities of the level detection system, preventing the ultrasonic level sensor from maintaining adequate contact with the reservoir. The risk caused by the detachment of the level sensor pad varies with the type of perfusion system that it is used with. In serious cases, it may cause interruption to blood flow due to unanticipated pump stop, which in turn, may lead to reduction in blood pressure and severe injury.
According to the local supplier, there is no record of distribution of the affected product in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.