Safety Alert Or Field Safety Notices for Heater-cooler devices used in cardiac surgery

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Maquet.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    MHRA issued a Medical Device Alert (MDA) on 11 June 2015 concerning all manufacturers of heater-coolers and the risk of patient infection with Mycobacterium species; this advice remains current.This information has highlighted an infection risk to open-heart surgery patients called non-tuberculous Mycobacterium (NTM).If the disinfection and maintenance procedures are not strictly followed, organisms can multiply in heater-cooler devices and a biofilm can be formed. The biofilm provides an opportunity for bacteria, including Mycobacteria, to colonise the device. Once colonised, there is a possibility that bacteria can become a source of patient contamination due to aerosolisation when the heater-cooler device is used, or contamination can spread during operational management of the device.
  • Reason
    Updated advice from manufacturers on device management for systems known or suspected to be contaminated with mycobacterium chimaera.
  • Action
    Notify the manufacturer and MHRA:of any heater-coolers known or suspected to be contaminated with Mycobacterium chimaera. The devices should be removed from service if you observe specific risks associated with the use of the heater-coolersNotify Public Health England and MHRA of any cases where patients have been infected with Mycobacterium chimaeraEnsure that the people responsible for operating and maintaining heater coolers are aware that specific advice has been issued by LivaNova (Sorin) and Maquet – details below.


  • Model / Serial
  • Product Description
    LivaNova (Sorin) has issued operational advice for the 3T heater cooler unit. Maquet has updated the HU35 cleaning and disinfecting instructions and will issue updated instructions for the HCU20, HCU30 and HCU40 soon.
  • Manufacturer


  • Manufacturer Address
    Sorin Group Deutschland GmbH (LivaNova) Christian Peis Director Quality Assurance Tel: +49 89 323 01 152Email christian.peis@livanova.comMaquet Bernd Rakow Director Regulatory Affairs Tel: +49 7222 932 1374Email
  • Source