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
Potential for the sterile empty 30 ml pca vial and injector (list no.6021-001) for use with hospira pca pump to leak from the injector at the mal luer lock end. leaking vials can result in drug waste during filling or delay in therapy if it occurs during administration. if the reported leakage had occured during use on a patient the most likely effect is a necessity to replace the pca vial at an unplanned time or administer supplemental medication.