Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
데이터 추가 비고
원인
Sorin has become aware that the actual disinfection practices and water maintenance by some users has not been conducted according to the ifu. without this organisms like mycobacteria can multiply in the heater cooler device and potentially form biofilm. fluid leakage or aerosolization generated by a contaminated water circuit during device operation could result in patient contact and a contaminated surgical site.