Safety Alert for GEMSTAR INFUSION PUMP / Model: 7 THERAPIES / ANVISA Registry # 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.

According to information provided by the company, it is important to routinely inspect Gemstar infusion pumps to identify possible signs of leakage, corrosion or damage as described in the System Operation Manual. If internal AA disposable batteries / batteries leak, their contents may cause damage to the internal components of the pump, which may result in its shutdown without audible or visual alarm. If the infusion pump switches off, therapy may be delayed or interrupted. If the infusion pump switches off, therapy may be delayed or interrupted. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. A delay / interruption in therapy or underdosing can in the worst case result in serious adverse event. As described in the Gemstar System Operation Manual, the enclosure and AA internal disposable batteries / batteries should be inspected for signs of leakage, corrosion, or other damage before each use. In addition, each time the disposable batteries are replaced, the battery compartment must be inspected for possible damage. The two expired disposable batteries must be replaced at the same time with alkaline disposable batteries. Depleted disposable batteries should not be used in the pump, even when the pumps are used with a backup power source (mains adapter) or with the rechargeable battery pack. If the infusion pump is damaged by leakage, immediately withdraw it from use and contact Hospira at 0800-7733133 to report the problem and request repair. Access the letter to the clients, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/cf4f7a804f869150b615f79a71dcc661/FA302-03_Messagem+de+Alerta.pdf?MOD=AJPERES #### UPDATED IN 23 / 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.