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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The separation of one or more posts that connect the mechanism frame to the bezel assembly may prevent the device from delivering an accurate amount of fluid flow through the pumping cycle resulting in an over or under infusion condition. in addition it may prevent the pump from alarming for an upstream or downstream occlusion condition. the separation of one or more posts are not visible to the end user. an over or under infusion may lead to injuries requiring medical intervention.