Events

Safety Alert for Advanced Perfusion System 1

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

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
    2012-03-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120322a.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
    Field safety notice: terumo®advanced perfusion system 1 medical device manufacturer, terumo cardiovascular systems, has issued a field safety notice concerning the 6” roller pump for the terumo® advanced perfusion system 1. terumo cvs has received reports of instances in which the 6” roller pump for the terumo® advanced perfusion system 1 displayed a pump jam message and stopped while in use. in the event of a stop on any pump, a pump stop creates user distraction while the user intervenes to adjust the tubing and/or occlusion setting in order to restart the pump. according to the local supplier, the affected device is not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation