Alerta De Seguridad para LABMAX 240

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LABTEST DIAGNÓSTICA S/A.

¿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
    966
  • Fecha
    2009-07-13
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    It has been found that lot 09/3880 of the O'ring 10 mm Labmax 240 product (Labtest 17173 code) may not work properly when installed in the equipment. The malfunction of this component allows the formation of bubbles in the body of the pumps of the modules SP, RP, PWP and CWP or the leakage of liquids, causing the loss of reproducibility of the analyzer. We note that the problem was identified only in lot 09/3880, with different batches being used without any restriction. Items collected will be restarted as soon as a new batch is available. Any clarification please contact the Automation Technical Assistance at 0800 031 34 11. Source: Labtest Diagnóstica S / A. Anvisa is accompanying the action of collecting such equipment.
  • Causa
    Water leakage occurs on the sp / rp / pwp pumps and the cwp module of the labmax 240 equipment due to improper adjustment of the o-ring sealing these pumps.
  • Acción
    Immediate discontinuation of use of this batch. Contact Labtest Automation Technical Assistance at 08000313411.

Device

Manufacturer