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.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
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Issue 1: the user is not able to turn off the pump when a pump in a distal occlusion paused state is exposed to a second "power off then on" malfunction. issue 2: when the user accesses the preventive maintenance screen in service/biomed mode on plum 360 v15.10.00.010 devices with a total delivery time greater than 1500 hours the user will not be able to interact with the device and the device must be power cycled.