Events

Alerta De Seguridad para HEMODIALISING MACHINE SPS-1550 (ANVISA Register: 10068390088).

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..

¿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
    1018
  • Fecha
    2010-05-07
  • 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 Baxter Hospitalar Ltda, as a result of a field correction performed in 2003 by the company, some hemodialysis equipment of the SPS 1550 model may contain electronic boards with wrong versions of software. The correct software versions for 1550 devices are 4.1B (for System 4 equipment) and 3.0A (for System 3 equipment). Software versions other than those listed above (on the side panel of the machine) display the incorrect "USE UF MANUAL" message when code errors FL04, FL07 and FL08 occur. Correct software versions (3.0A and 4.1B) display the message "DISCOUNT TX" (TX = Treatment) in the occurrence of these same error codes. The company has already sent a letter of communication and is making available the correct software update for its clients. #### Update: The action was closed by the company in December 2010, according to a letter sent to UTVIG (File: 009119 / 11-7 , 05/01/2011). According to Baxter, all customers (286) were notified and visited by company technicians for software upgrades.
  • Causa
    The equipment may issue an incorrect instruction to the user, leading to continuation of hemodialysis therapy in situations in which it should be discontinued.
  • Acción
    To health facilities: If you have this equipment at your health facility, proceed as follows: (1) Identify the software version of your equipment, following the manufacturer's instructions (see attachment); (2) If the software version of your equipment is different from versions 3.0A or 4.1B, instruct equipment operators to discontinue the treatment whenever the dialer side panel reports error codes FL04, FL07 or FL08, disregarding the UF MANUAL "instruction that will appear (this message is incorrect for the mentioned error codes). It is highly recommended that a written, easily identifiable work instruction be placed near the equipment panel that alerts operators to the problem.

Device

HEMODIALISING MACHINE SPS-1550 (ANVISA Register: 10068390088).

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA