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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During internal testing livanova identified a possibility that automatic line closure by the electrical remote-controlled tubing clamp (erc) after detection of an air bubble could take longer than is intended by design in the cp5 system. this could lead to the remote possibility of an air bubble reaching a patient before the clamp closes if the blood flow rate is high and the distance between the bubble sensor and the patient is set at the minimum required by the ifu (1 meter).