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
Terumo cardiovascular systems (terumo cvs) has become aware through internal testing that the terumo advanced perfusion system 1 operator's manual does not completely describe the system's centrifugal pump response under certain conditions. specifically if the user is adjusting the pump speed using the central control monitor (ccm) or the manual speed knob on the centrifugal control unit at the same time an event occurs (which would activate the coast response mode on the pump).