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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Terumo cardiovascular systems (terumo cvs) has received multiple reports of false alarms generated by the air bubble detection system used with the terumo advanced perfusion system 1 the sarns modular perfusion system 8000 and the sarns perfusion system 9000. terumo cvs' investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore terumo cvs has concluded that it is necessary to amend the operator's manuals for its heart-lung machines to: - alert all users of the potential for a malfunction of the air bubble detection system - reinforce the mitigation procedures in the event of a malfunction.