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 is notifying users of a range of potential issues that may be observed with colleague p1.5 volumetric infusion pumps. these issues include: occlusion detection sensor failure caused by fluid ingress variations in pump accuracy if a pump is dropped an electric circuit that does not comply with international safety standards an internal communication failure that will result in pump shutdown (see 2008fca18) and various battery maintenance problems (see 2008fca18).