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.
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Sorin group usa received a safety alert from terumo cvs for their cdi h/s cuvette which is included in custom heart lung packs manufactured by sorin group usa. this safety alert calls attention to a situation that may arise with the cdi h/s cuvette and recommends how to respond should the cdi blood parameter monitoring system 500 display the error message "h/s disconnect at cuvette." this may occur when the cdi h/s cuvette does not make a proper connection to the cdi h/s probe. in this situation blood parameter values for hct hgb and so2 do not display.