Events

Safety Alert for Level Sensor II Pads

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Terumo Cardiovascular Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2011-08-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20110818.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device removal: terumo level sensor ii pads 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.

Device

Level Sensor II Pads

Manufacturer

Terumo Cardiovascular Systems