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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If the plum a+ fluid shield diaphragm is out of specification it may cause n250 "door open while pumping" or n100 "unrecognizable cassette" alarms. both the n250 and n100 alarm conditions trigger an audible and visual warning to the user which may occur during setup infusion or performance verification testing (pvt).
Model Catalog: 20792 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 20679 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 12391 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 20678 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 12618 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 11005 (Lot serial: ALL SERIAL NUMBERS)