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 has received complaints for repeated system error 322 "link switch error (low)" occurrences with the sigma spectrum infusion system. this error may occur when there is a miscommunication with the two internal switches that detect door closure. if system error 322 occurs during infusion the sigma spectrum infusion system stops infusing. an audible alarm and visual alarm will also occur.