LivaNova Stöckert 3T Heater-Cooler Device — recall 56137

Reported risk: Health Canada is aware of Canadian and international reports of nontuberculous mycobacteria (NTM) infections associated with the HCDs used in cardiothoracic surgery. In addressing this issue, on October 21, 2016, Health Canada issued a safety alert titled: “ Important Safety Information on Heater-Cooler Devices - Risk of Nontuberculous Mycobacteria Infections ”. Footnote 1 Since that time, Health Canada has continued to review available information and to work with the manufacturers of all HCDs licensed in Canada to develop strategies to further mitigate the risk of NTM infections. Evidence reviewed suggests that 3T HCDs manufactured by LivaNova prior to September 2014 are at an increased risk of contamination with M. chimaera , a type of NTM. Footnote 2 To date, cases of M. chimaera infection associated with the use of HCDs in Canada and internationally have only been reported for 3T HCDs manufactured prior to September 2014. Footnote 2 Stöckert 3T heater-cooler devices, manufactured by LivaNova (formerly Sorin) prior to September 2014. Evidence has shown that the LivaNova manufacturing site for 3T HCDs in Germany was likely a source of M. chimaera contamination for devices manufactured prior to September 2014, suggesting a point-source of contamination. Footnote 3 , Footnote 4 , Footnote 5 LivaNova has implemented changes to their manufacturing processes to reduce the risk of NTM contamination of 3T HCDs released after September 2014. Footnote 2 Routine cleaning recommended by the manufacturer is intended to prevent bacterial contamination, but it is insufficient once the devices have been contaminated for a long period of time (due to biofilm formation). Footnote 6 A deep-disinfection procedure was implemented by LivaNova to allow facilities to return their contaminated 3T HCDs for a full cleaning, disinfection and replacement of connectors and tubing. Information from the manufacturer suggests that the deep disinfection process is a means to eliminate M. chimaera contamination in the HCDs. With regard to routine monthly testing to detect M. chimaera in water samples collected from HCDs, the Canadian Public Health Laboratory Network (CPHLN) has identified multiple limitations impacting the accuracy and reliability of results . In particular, these limitations include the lack of standardized and validated methods for sample collection, processing and detection of M. Chimaera . As a result, the value of routine monthly device testing is limited as a reliable means to determine the status of M. chimaera contamination in HCDs.