Safety Alert for GEMSTAR INFUSION PUMP - Record 80253310025 - All lots.

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.

According to research by the manufacturer, the root cause is associated with the excessive force required to remove the cable to administer the bolus. This excessive force may result in bolus administration failures, in addition to possible open circuit or Bolus cable short circuit. There are no notifications related to this problem, so far on the NOTIVISA system. Anvisa is following this action. #### UPDATE - 08/14/2012 - The company forwards the Final Report of the Field Action, stating that 100% of the clients were informed of the handling with the handle of the bolus cable of the Infusion Pump - There is no mention of altering the project. #### UPDATE (04/02/2015): HOSPIRA forwarded a new field action report (FA203-01) concerning the replacement of old bolt cables with new cables, the new drawing seeks to avoid premature rupture. Customers will receive the new cables from HOSPIRA and will have to replace them - the old cables must be destroyed by the customers themselves, or sent to the company for destruction. The completion of the replacement is scheduled for March 31, 2015.