Events

Safety Alert for Sarns Soft-Flow Aortic 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
    2012-12-24
  • Event Date Posted
    2012-12-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121224.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 soft-flow aortic cannulae medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning sarns soft-flow aortic cannulae. affected catalogue numbers are 5762, 5768, 5774, 5841, 5843, 5845, 5847, 7071, 7072. during in-house inspection, terumo cardiovascular systems (terumo cvs) identified the presence of excess plastic material, or flash, on the tip of the sarns soft-flow aortic cannula. the flash has the potential to detach. terumo cvs’ investigation revealed that: the flash occurred during the molding process of the cannula tip. other product lots may exhibit the same issue. the mold was corrected to resolve the observed condition. terumo cvs is advising users to discontinue use and return all affected cannulae in inventory. it is because the presence of plastic flash on the cannula tip may or may not be visually detected by users. if plastic flash material is present, there is the potential for it to become dislodged and deposited in the patient’s vascular system resulting in varying degrees of patient harm, depending on the size of the dislodged material, the location in which it is deposited, and the condition of the patient. potential outcomes include inflammatory response which can create clot, ischemia, or tissue death. according to the local supplier, the affected products have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 24 december 2012.

Device

Sarns Soft-Flow Aortic Cannulae

Manufacturer

Terumo Cardiovascular Systems Corporation