Sorin Group perfusion system – Heater Cooler 3T devices 에 대한 현장 안전성 서한

Field Safety Notice

2017-05-03

Slovenia

AMPMDRS

Over the past two years, livanova and the broader cardiac surgery community has learned a great deal about a newly-identified infection risk to open-heart surgery patients called nontuberculous mycobacterium (“ntm”). ntm are widespread in nature and are commonly found in the soil, natural water, drinking water distribution systems, and household and building plumbing, especially in recirculating hot water systems in hospitals and apartment buildings. ntm are typically not harmful, but in rare cases may cause infections in very ill patients or individuals with compromised immune systems. in june 2015, sorin group deutschland gmbh, now livanova deutschland gmbh, issued a field safety notice regarding “cardiac surgery mycobacterium risks; disinfection and cleaning of sorin heater cooler devices” (attachment 1) to mitigate a potential risk of patient infection by non- tuberculous mycobacteria released from the heater-cooler 3t. in october 2016, following several communications related to nontuberculous mycobacterial (ntm) infections associated with the use of heater-cooler devices issued by the united states centers for disease control and prevention (cdc) and food and drug administration (fda), livanova distributed a second fsn (attachment 2) reiterating and supplementing some of the recommendations contained in the june 2015 fsn. additionally, the october 2016 communication indicated that, livanova continued to develop solutions that further mitigate the potential risk of m. chimaera contamination, working closely with the regulatory authorities to obtain approval. .