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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For dialysis patients with ascites using homechoice and homechoice pro devices with software version 10.4 because the device will attempt to drain the patient to empty during the initial drain there is an increased risk of hypotension and compromised hemodyamic status.