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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The roller pump displayed a jam message and stopped while in use. it is more likely to occur when using the 6" than using the 4" roller pump for dual sized tube set cardioplegia delivery. the occlusion settings suggested in ifu for some dual-sized tubing sets may increase the likelyhood of pump jam on 6" roller pump.