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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Baxter corporation has been made aware that users may not be following the instructions in the operator's manual and incorrectly opening disposable set packaging while setting up their peritoneal dialysis (pd) therapy damaging the cassettes for the homechoice or homechoice pro system. if damaged cassettes are used the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.