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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Maquet cardiopulmonary has been receiving complaints for the quadrox-id adult and quadrox-id small adult diffusion membrane oxygenators as well as the oxygenators contained in hls and pls sets (due to the similarities of the oxygenator contained in these sets) regarding blood leaking from the gas outlet connector (or the area at the lowest part of the oxygenator) and has noticed an increase in the frequency of these reports.