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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A lithium battery that is not user accessible is used to power the memory that stores the current infusion settings and the event history logs when the pump is turned off. if the battery's voltage level drops below 2.4 volts an 11/004 error will be displayed and the device will not be able to be used resulting in a possible delay/interruption in therapy.
Model Catalog: 13150 (Lot serial: All Serial Numbers); Model Catalog: 13087 (Lot serial: All Serial Numbers); Model Catalog: 13088 (Lot serial: All Serial Numbers); Model Catalog: 13000 (Lot serial: All Serial Numbers)