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 is issuing a device correction for the sigma spectrum infusion pump with master drug library (spectrum infusion pump) in order to replace speakers installed in pumps that have an increased potential to fail prematurely. the speaker is intended to generate audible tones during each keystroke and during alarm conditions. however some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. spectrum infusion pumps with non-functional speakers will continue to display visual alarm indications and will otherwise continue to operate as intended. before using an affected spectrum infusion pump users should confirm the generation of an audible tone as instructed in the device operator manual.