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
Baxter corporation the current device licence holder is providing a follow-up to earlier notices from edwards lifesciences the previous device licence holder concerning edwards aquarius software versions 4.01.11 and 4.01.12 and reports of significant fluid imbalance in patients related to repeated overriding of the fluid imbalance alarms of the aquarius system software contrary to the operating manual of the device.