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.
데이터 추가 비고
원인
Pc unit model 8000 when used with pump or syringe modules may under certain conditions display an incorrect total dose when programmed to deliver bolus dose. the pump or syringe module delivers the actual programmed bolus dose (and associated volume to be infused) regardless of the displayed total bolus dose. this can cause confusion leading to improper treatment potentially causing injury or death.