Events

Alerta De Seguridad para Technical Name: CENTRIFUGAL PUMP FOR CARDIOPULMONARY BY-PASS SYSTEM Registration Number: 80102511251 Hazard Class: III Model Affected: S5, C5 Serial Numbers Affected: NS 16S15049 and 16S15050

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR Medical Importadora e Distribuidora de Prods Médicos Ltda; LivaNova Deustchland GmBH (previously Sorin Deustchland 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
    2286
  • Fecha
    2017-05-15
  • 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
    VR Medical does not have complaints records of the Ação products, since its installation is recent in the country, but we recommend that the professionals carry out
  • Causa
    Livanova detected risks of contamination by mycobacterium during cardiac surgeries when using the sorin - livanova coolant devices by the 3t heater / cooler when it is not subject to the cleaning and decontamination procedures recommended by the manufacturer. said heather cooler (heater / cooler) is an accessory in the perfusion system product registered by vr medical in brazil.
  • Acción
    Field Action Code AC006 / 17 triggered under the responsibility of the company VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA. Company will make correction in the field.

Device

Technical Name: CENTRIFUGAL PUMP FOR CARDIOPULMONARY BY-PASS SYSTEM Registration Number: 80102511...

Manufacturer

VR Medical Importadora e Distribuidora de Prods Médicos Ltda; LivaNova Deustchland GmBH (previous...
  • Source
    ANVSANVISA