Events

Alerta De Seguridad para Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class I, Serial Number: 7501721; 7501821; 7501921; 7502021.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

¿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
    1706
  • Fecha
    2015-10-01
  • 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
    Unexpected spills, aerosols, or blood droplets may occur when equipment is improperly unplugged. There are no known cases of serious adverse events. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Inadvertent opening of the sample tube during the transport process with risk of user contamination and sample loss. the root cause of the problem is related to the design of the repellent plate bevel, which is the component of the tube inlet basin.
  • Acción
    The company will make a field correction of the equipment in which it will develop a kit of modification for the equipment. Until the corrective measure with the modification kit is implemented, if the problem occurs, the equipment must be cleaned according to the operating manual.

Device

Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH