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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A certain diode on the pcb assembly that may result in insufficient voltage to a portion of the pump. if this condition occurs the pump will display "er13" and immediately sound an alarm or the pump will shut down entirely. if the er13 error occurs after initiation of the pump operation there is a small potential for a delay in therapy. although unlikely a delay in therapy could result in a patient not receiving prescribed nutrition and may pose a potential for dehydration or hypoglycemic episode. no illnesses or injuries have been reported as of the date of this notification.