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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Smiths medical has found that pumps with obsolete software versions 2.0.2 2.0.3 and 2.0.4 may continue to run past the set volume limit if all of the following occur: 1) the volume over time (delivery method) mode is used 2) the volume over time mode is re-accessed through the "recall last settings" function and 3) the syringe is over-filled.