Safety Alert for Gemstar Infusion Pump / Model: 7 Therapies / ANVISA Registration # 80253310025.

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.

When turning on the infusion pump (self-test - POST) or during an infusion, users can check error code X09 / 001 which indicates the movement of the motor back. They may also observe visual and audible alarms, indicating that the infusion will be interrupted or will not start, resulting in delayed or interrupted therapy. Rates lower than 2.0 mL / h can cause the motor to move in the opposite direction, capturing fluid that will be administered, resulting in overdose. http://portal.anvisa.gov.br/wps/wcm/connect/384de7004f86917fb61ef79a71dcc661/FA302-04_Message+of+Alerta.pdf?MOD=AJPERES Severity in the delay or interruption of therapy depends on the patient's underlying condition and treatment prescribed. A delay / interruption in therapy can in the worst case result in serious adverse event. Hospira indicates the following restriction of use in clinical practice: do not use Gemstar infusion pumps in neonates and infants up to 2 years of age and any patients where therapy is given at rates below 2.0 mL / h. If the Gemstar infusion pump generates error code X09 / 001, remove it from use and contact Hospira by calling 0800-7733133 to report the problem and request repair. Health professionals are advised to evaluate the risks / benefits to patients associated with the use of the equipment when administering critical therapies. Clients should contact a Hospira representative for the use of an alternative pump, particularly for patients in whom delayed / discontinued therapy or overdose can lead to serious injury or serious adverse events. Access the letter to the clients, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/384de7004f86917fb61ef79a71dcc661/FA302-04_Messagem+de+Alerta.pdf?MOD=AJPERES #### UPDATED AT 22 / 08/2017, the field action documentations sent by the company are filed in the area. If necessary, the area can reassess the action at any time.