Organization: Health Canada
Year: 2024
Month: October
Request Number: A-2018-000759
Request Summary: Any adverse event report received by Health Canada from patients, health care professionals or health care institutions in the Province of Québec who have reported adverse events associated with heater cooler devices including, but not limited to, heater-cooler systems manufactured by Sorin Group Deutschland GMBH or Maquet Cardiopulmonary GMBH relating to potential Mycobacterium chimaera infections. All correspondence between the Health Canada and the patients, health care professionals or health care institutions in the Province of Québec who have reported Adverse Events. The results of any analysis relating to the Adverse Events conducted by or on behalf of Health Canada, or communicated to Health Canada. All communications between Health Canada and the Laboratoire de santé publique du Québec or the Institut national de santé publique du Québec relating to the Heater-Coolers and any potential Mycobacterium chimaera infections. Any other communications between Health Canada and health care professionals or health care institutions in the Province of Québec relating to a risk of Mycobacterium chimaera infections associated with the use of Heater-Coolers.
Disposition: Disclosed in part
Number of pages: 293