Events

Safety Alert for advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000

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
    2012-06-22
  • Event Date Posted
    2012-06-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120622.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 advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000 medical device manufacturer, terumo cardiovascular systems (cvs) corporations, has issued an urgent field safety notice concerning terumo advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ perfusion system 9000. the manufacturer has received multiple reports of false alarms generated by the air bubble detection system used with perfusion system of the above models. it will possibly result in temporary interruption of arterial blood flow, air entrainment in the system, or the need to continue the case with a disabled air sensor. there have been no reports of patient injury as a result of this failure. their investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore, terumo cvs has amended the operator’s manuals for its heart-lung machines to alert all users of the potential for a malfunction of the air bubble detection system and to reinforce the mitigation procedures in the event of a malfunction. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 june 2012.

Device

advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion sy...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo Advanced Perfusion System 1, Sarns™ Modular Perfusion System 8000 and Sarns™ Modular Perfusion System 9000
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems