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.

Calibration of the proximal and distal pressure sensor may vary, resulting in failure of the pump's Proximal or Distal Occlusal Operation Test as described in the GemStar Service Technical Manual, or exhibiting one of the following errors during infusion or pump configuration : Check Cassete - D; Check Cassete - P; Proximal occlusion; Distal occlusion; Pressure Calibration Error; Damaged Pressure Sensor Event; Damaged Pressure Sensor Status; Distal Pressure Out of Limit; Proximal Sensor Off limit. A pump with this problem may, instead of reporting an error, not detect occlusions or emit false occlusion alarms, which will interrupt the infusion and cause the device to emit visual and audible alerts. If these failures are observed the infusion is interrupted, resulting in delayed / interrupted therapy. An undetected distal occlusion can cause excessive pressure and accumulation of fluid in the distal line not detected by the pressure sensor. When distal occlusion is resolved, fluid accumulation will be administered to the patient and may cause a maximum overdose of <1.0 mL. 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 may, in the worst case, result in a serious adverse event. 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. It is recommended to perform proximal and distal occlusion tests as described in the Gemstar Technical Service Manual. If the pump fails one of the tests, it must be withdrawn from use. If you are unsure whether to perform the tests or if the infusion pump fails during one of the tests, contact Hospira on 0800-7733133 to report the problem and send the pump for recalibration. Performing distal and proximal occlusion tests should be included in the annual preventive maintenance schedule. Access the letter to the clients, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/a59744804f8690b9b60cf79a71dcc661/FA302-02_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.