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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There is the potential risk for an air embolism if air is delivered to a donor due to the failure mode of operator error in which the donor is connected prior to completion of loading the tubing set when using the trima accel system. terumo bct is aware of nine reported events related to this failure mode. given this potential risk terumo bct is voluntarily implementing a safety enhancement in the trima accel system software version 5.1.9 and version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. the safety enhancement is called air reduction mitigation (arm).