M. chimaera Infections Associated with 3T Heater-Cooler Devices

Invasive infections due to slow-growing nontuberculous mycobacteria, M. chimaera, have been identified in patients in Europe and the United States after open chest surgery using the LivaNova Sorin Stockert 3T (Sorin 3T) heater-cooler device. Heater-cooler devices are used in operating rooms with life-saving cardiopulmonary bypass machines to control core body temperature during open chest cardiac surgery. The devices have closed water circuits that do not come into contact with patients.  Stockert Sorin 3T heater-cooler devices may have been contaminated with M. chimaera during the manufacturing process.  Investigation has confirmed that contaminated Sorin 3T heater-cooler devices can aerosolize and expose patients to M. chimaera during open chest surgical procedures.  This webpage provides California Department of Public Health (CDPH) information for clinicians and local public health officials, and links to the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommendations.

Information updated November 28, 2016

CDC produced a video to provide important information for heart surgery patients. Patients seeking information should contact their medical providers or hospitals. 

Information for Hospitals

• All-facilities letter (AFL) 16-16: Mycobacterium chimaera Infections Associated with Exposure to Sorin 3T Heater-Cooler Devices during Open Chest Cardiac Surgery
  (Updated November 28, 2016 - Supersedes AFL 16-12)

• Infection Control Checklist for Sorin 3T Heater-Cooler Devices

Information for California clinicians and local public health officers

• CDPH Summary Brief: Mycobacterium chimaera Infections Associated with Exposure to Sorin 3T Heater-Cooler Devices during Open Chest Cardiac Surgery (Updated November 28, 2016)

• CDPH Guidance for Physicians and Local Public Health Officials: Mycobacterium chimaera Infections Associated with Exposure to Sorin 3T Heater-Cooler Devices during Open Chest Cardiac Surgery

• Educational webinar October 14, 2016: M. chimaera Infections Associated with Exposure to Sorin 3T Heater-Cooler Devices during Open Chest Surgery: What Clinicians Need to Know 
  Webinar Slides (coming soon)

• Case Descriptions: M. chimaera Associated with Heater-Cooler Device

• References: M. chimaera Associated with Heater-Cooler Device

Federal guidelines and recommendations

• CDC Contaminated Heater-Cooler Devices webpage

• CDC Advises Hospitals to Alert Patients At Risk From Contaminated Heater-Cooler Devises used During Cardiac Surgery, CDC Health Advisory October 13, 2016

• CDC Heater-Cooler Notification Toolkit

• CDC Interim Guide for the Identification of Possible Cases of Nontuberculous Mycobacterium Infections Associated with Exposure to Heater-Cooler Units, May 13, 2016

• CDC Interim Practical Guidance: Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices , October 27, 2015

• FDA Heater-Cooler Devices webpage

• FDA Safety Communication UPDATED: Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System, October 13, 2016

• FDA Safety Communication: Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System, June 1, 2016 (archived)

• FDA Safety Alert: Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: Communication, October 15, 2015

Please contact us with questions at HAIProgram@cdph.ca.gov