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

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.

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.