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.
데이터 추가 비고
원인
The alaris pump module model 8100 manufactured between august 2010 and july 2011 may experience an intermittent motor stall during infusion. the investigation revealed that a mechanical binding within the mechanism assembly is resulting in a motor stall. when a motor stall occurs the alaris pc unit and the alaris pump module display the visual error code 242.4030 with an audible alarm and is followed by a termination of infusion.