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 a safety alert for coiled tube infusors noting that a labeling error previously communicated to customers on march 5 2014 when combined with all other use factors can contribute to infusion rates in excess of 30% greater than the nominal (labeled) flow rate. delivery of medication at an infusion rate faster than intended may lead to toxicity and changes to efficacy that require medical intervention.