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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1) possible impact of significant vibration or jarring to omnifuse pumps: due to sensitivities of the precision accuracy detection mechanisms within omnifuse pumps certain levels of vibration or jarring during transport can induce a system fault code. 2) affect on the totaliser display after resetting the pump to clear a system fault: if a system fault code occurs during an infusion and the pump is reset the totaliser display will not include the most recent infusion data.