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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Change to 1 (one) page on an instruction card set that attaches to the 3860 units. iradimed corp continues to investigate reports of possible fluid free flow and concluded that stretching or improper placement of the iv set during pump set up is the primary cause of these reports. in 2012 iradimed customers received an updated quick reference instruction card which emphasized proper placement of iv set during pump set up. since that time newer customers did not receive this updated quick reference instruction card. though no incidence of injury have occured iradimed is proactively re-issuing this notice to assure the continued safe use of mridium mr infusion pump systems.