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 in conjunction with health canada is providing this notice to reinforce the importance of proper programming to reduce the potential for unintended increased intraperitoneal volume (iipv) or overfill of the abdomen in patients using the homechoice and homechoice pro apd systems. unintended iipv can occur if the prescription parameters are not programmed appropriately in the dialysis systems and this can lead to serious injury or death.