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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The pump uses an optical sensor to detect the presence of fluid or air in the administration set which is why at the completion of a feeding it is expected that the pump will alarm as outlined above. however residual clumps from certain types of feeding preparations may be interpreted by the sensor as food remaining in the administration set causing the pump to continue to run despite the bag being empty. this situation likely occurs with home blended or prepared food as well as non-traditional additives such as fortifiers lipids proteins etc. if the sensor is obstructed by sticky solids it may cause the pump to continue running and cause an overrun failure and may potentially deliver air to the users.