Events

Safety Alert for Soft-Flow® Aortic Cannula with angled tip

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
    2012-03-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120310a.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 soft-flow® aortic cannula with angled tip medical device manufacturer, terumo cardiovascular systems corporation, has issued a field safety notice concerning soft-flow® aortic cannula with angled tip. during an in-house inspection, terumo cardiovascular systems (terumo cvs) identified an unintended hole in the side wall of the angled tip of a soft-flow® aortic cannula. the manufacturer’s investigation suggests that the defect occurred during the tip bending process. potential hazards include the following: if the defect is noticed prior to insertion, patient risk is limited to those harms associated with substitution of the product and the resulting delay of the case. if the defect is not noticed before insertion, there is a potential for a constant, high pressure blood spray following insertion from the defect in the cannula tip and the operating pressure to which the cannula is typically exposed, leading to blood loss and an increased risk of blood exposure to the cardiac team. if the defect is discovered after insertion and requires replacement of the device, change-out of the product will be necessary. this could encompass: additional manipulation of the aorta and the risk of tissue damage, from a slight tear to a dissection requiring surgical intervention, small amounts of air could be entrained through the hole and into the aorta, leading to potential embolic events, delay of case and any harm that might relate to hypotension based on the duration of the replacement process and the stability of the patient during the process. there has been no report of patient injury as a result of this issue. terumo cvs is alerting its customers to stop using the affected devices. according to the local supplier, affected devices have not been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

Soft-Flow® Aortic Cannula with angled tip

Manufacturer

Terumo Cardiovascular Systems Corporation