Events

Alerta De Seguridad para Hypothermia / Hypertemia System HCU 40 Technical Name: Body Temperature Control Equipment ANVISA Registration Number: 10390690089 Hazard Class: III Model Affected: HCU 40 Serial Numbers Affected: 90440288 and 90440289

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO 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
    2257
  • Fecha
    2017-04-03
  • 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
    • Upgrading your HCU 40 systems must be performed by Maquet's authorized service personnel in accordance with Upgrade Instruction - FSCA-2016-11-30 - Heating-Cooling Unit HCU 40 (MCV-UI-10000833-EN- 01) as soon as possible. • Complete the attached Recognition Form and return it as soon as possible to your local Maquet representative. • Incorporate the new cleaning and disinfection procedures into your operation processes, and perform any necessary training. • Continue to monitor hygiene (levels of contamination) according to your internal practices. • Immediately report any contamination findings to your local Maquet representative by filing a complaint.
  • Causa
    Maquet cardiopulmonary, as well as different competent national authorities, received isolated reports indicating bacterial contamination in the hcu 40 system water, including mycobacterial counts. maquet has not received any reports that a mycobacterial infection has been caused by a hcu 40. our investigations have shown that the currently published disinfection procedure of the hcu 40 system waterways (in the instructions for use) should be improved as to effectiveness against atypical mycobacteria. in this context, it is important to know that a hazard to the patient due to escape of microorganisms during the operation of the heating-cooling unit hcu 40 can be excluded with near absolute certainty. an independent testing institute also concluded that.
  • Acción
    Field Action Code FSCA-2016-11-30 triggered under the responsibility of the company MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA. Company will make correction in the field.

Device

Hypothermia / Hypertemia System HCU 40 Technical Name: Body Temperature Control Equipment ANVISA ...

Manufacturer

MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA.
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    ANVSANVISA