Events

Field Safety Notices about Sorin Group perfusion system – Heater Cooler 3T devices

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by LivaNova Deutschland GmbH.

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
    Field Safety Notice
  • Date
    2017-05-03
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    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. .

Device

Sorin Group perfusion system – Heater Cooler 3T devices

Manufacturer

LivaNova Deutschland GmbH