Events

Safety Alert for Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae

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
    2014-03-07
  • Event Date Posted
    2014-03-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140307c.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 sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning all lots of sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae with catalogue numbers 4934, 4934x, 4935, 4936, 4936x, 16472 and 16473. during in-process inspection, terumo cardiovascular systems (terumo cvs) identified exposed basket wire on certain product lots of sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae. according to the manufacturer, the presence of exposed basket wire on the outside surface of the cannulae may be detected by the surgical team prior to patient exposure. if not detected, the exposed wire could result in tissue damage and a remote chance of air being introduced into the cardiopulmonary bypass circuit. the presence of exposed basket wire on the inside surface of the cannulae is more difficult to detect. the exposed wire could result in turbulence in blood flow increasing risk of hemolysis. terumo cvs has not received any reports of exposed basket wire from customers and there are no reported injuries from the observed defect. terumo cvs is recalling all affected cannulae. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.

Device

Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation