Events

Safety Alert for Arterial and Cardioplegia Monitor for Sarns Modular Perfusion System 8000

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
    2012-11-02
  • Event Date Posted
    2012-11-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121102b.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 safety alert: terumo arterial and cardioplegia monitor for sarns modular perfusion system 8000 medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has initiated a field safety corrective action concerning the arterial and cardioplegia monitors for sarns modular perfusion system 8000. terumo cvs has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular perfusion system 8000. the malfunctions can be broadly categorized as follows: monitor power malfunctions inability to measure pressure inaccurate pressure readings and/or false pressure alarms terumo cvs’ initial investigation has determined that while the operator’s manual for the sarns system 8000 provides instruction on how to respond to the malfunctions, the manufacturer believes the instruction can be clarified for responding to false alarms. there are no known reports of patient injury as a result of these issues. furthermore, the manufacturer is notifying all affecteds users of the possibility of malfunction and reminding them to review the appropriate sections of the operator’s manual, and providing an addendum to the operator’s manual to clarify instruction on how to respond to a false alarm. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 2 november 2012.

Device

Arterial and Cardioplegia Monitor for Sarns Modular Perfusion System 8000

Manufacturer

Terumo Cardiovascular Systems Corporation