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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Slow leak at the luer connection to the cardioplegia table line in various myocardial protection sets. air entrainment has been observed in the table line in each case of air entrainment the leaking connector had been exposed to negative pressure such as would occur when using an aortic vent in conjunction with the myocardial protection set.