Events

Safety Alert for Colleague Infusion Volumetric Pump, BAXTER Brand, Colleague Model, Colleague 3, Colleague CXE and Colleague CXE 3 - Registration Number 10068390320 /// Serial Number: 21120161DC, 22020018DC, 22030018DC, 22030000UC, 22040046UC, 22040071UC, 22040089UC, 22040104UC, 22050072DC, 22050406UC , 22060024DC, 22060720DC, 22060946DC, 22061138DC, 22061204DC, 22070050UC, 22070198UC and 22070444DC.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch..

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
    1510
  • Date
    2014-12-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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.
  • Extra notes in the data
    According to manufacturer's information, using the Colleague infusion pump with old wiring may result in an inaccurate time remaining battery level or the option to operate with battery power may become unavailable. In the event of a failure or event with the battery (which is extremely unlikely to occur), this situation could contribute to a delay in infusion or interruption of the infusion.
  • Reason
    According to the information disclosed by the company, 18 serial numbers of the colleague pump were identified that had the "yuasa" battery replaced during service, but battery wiring was not changed as required in the specification.
  • Action
    The company will correct the devices in the field and send Letter to the Client (SEE ANNEX) to those who have the equipment affected. Segregation of affected equipment is requested and completion of the Customer Response Form (APPENDIX). Once completed, send it to fax number 0 (XX) 11 5653-0106 or email faleconosco@baxter.com. LIST OF EQUIPMENT DISTRIBUTION IN ANNEX.

Device

Colleague Infusion Volumetric Pump, BAXTER Brand, Colleague Model, Colleague 3, Colleague CXE and...

Manufacturer

Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch.