Events

Alerta De Seguridad para 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.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1510
  • Fecha
    2014-12-16
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la 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.
  • Causa
    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.
  • Acción
    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.