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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Baxter corporation is issuing an urgent medical device correction for certain sigma spectrum infusion pumps with master drug library (v6) due to the potential that a small number of these pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication. this could potentially result in over- or under-infusion.