Events

Alerta De Seguridad para SARNS ARTERIAL CANAL (Anvisa Record n ​​° 80012280001). LOTS AFFECTED: Code 12315, lots: 0652905; 0666574 / Code: 13010, lots: 0644444; 0646144; 0653230; 0666586 / Code: 13020, lots: 0570455; 0574279; 0640518; 0646396; 0666719 / Code: 13030, lots: 0570456; 0571580; 0640980; 0650900

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por TERUMO CARDIOVASCULAR SYSTEMS; TERUMO MEDICAL DO BRASIL 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
    1140
  • Fecha
    2012-06-14
  • 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
    During production of a batch of the Sarns High Flow Aortic Cannula, the Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannula connectors. Terumo CVS's preliminary investigation has noted that the substance may be displaced from the surface of the cannula and is likely to be deposited during the molding process - the exact composition of the particle is still undetermined. While Terumo CVS has no other documented examples of this substance appearing during production, the company has determined that all units manufactured in the last three years in the same mold could have been potentially affected. For further information regarding this field action, please visit: http://portal.anvisa.gov.br/wps/wcm/connect/29cca4804b9e0545b6f7b6af8fded4db/Messagem_de_Alerta.pdf?MOD=AJPERES For Company Response Form, go to: http: / / /portal.anvisa.gov.br/wps/wcm/connect/f39d0f804b9e04c7b6d0b6af8fded4db/Formula_de_Resposta.pdf?MOD=AJPERES
  • Causa
    During the production of a product batch, terumo cardiovascular systems (terumo cvs) encountered a foreign substance on the outer surface of some cannula connectors.
  • Acción
    According to Terumo it is a stock picking action (physical removal) from its point of use to some other location for destruction. If you have affected products in your facility, you must: (1) Review the Medical Device Removal notification; (2) Ensure that all users are aware of this notification; (3) segregate the identified affected products into your inventory; (4) Complete and return the Response Form (attachment) as soon as possible, indicating the number of units affected in your institution; (5) Contact Terumo Medicai do Brasil for local destruction instructions.

Device

SARNS ARTERIAL CANAL (Anvisa Record n ​​° 80012280001). LOTS AFFECTED: Code 12315, lots: 0652905;...

Manufacturer

TERUMO CARDIOVASCULAR SYSTEMS; TERUMO MEDICAL DO BRASIL LTDA