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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by HOSPIRA PORDUTOS HOSPITALARES LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Possible faults may be a result of the damaged bolus cable.
  • Action
    The manufacturer is doing studies to lessen the vulnerability of the Gemstar Pump bolus delivery cable. Meanwhile, customers are being instructed to carefully handle the cable in order to avoid problems. See attached Letter to Customers.


  • Manufacturer Parent Company (2017)
  • Source