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.
데이터 추가 비고
원인
Lifecare pca pumps were manufactures with incorrect motor composents.The motor of affected pumps may slip during pca delivery resulting in a code 630 error. if a 630 error code occurs audible and visual warnings are triggered and the infusion will stop resulting in a delay/ interruption of therapy.