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 desired cardioplegia temperature may not be obtained when the plegiox cardthe desired cardioplegia temperature may not be obtained when the plegiox cardioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler ioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler unit. isolated field reports have indicated that a user could not reach a desired low cooling temperature of cardloplegic solution as the measured value of the cardioplegia temperature by the probe on the plegiox did not match the set temperature on the heater/cooler unit. this variation has been attributed to the position of the temperature probe at the port on the plegiox which may lead to temperature readings differing to a varying degree from the real temperature of the cardioplegic solution. the discrepancy between cardioplegia temperature measured at the probe of the plegiox and set water temperature on the heater/cooler unit may appear greater than typical during clinical use of the heater/cooler system.