Events

Alerta De Seguridad para Trade name: HEMODIALISE BELLCO MACHINE /// Medical Product Model: FORMULA 2000, FORMULA 2000 PLUS, FORMULA PLUS and FORMULA THERAPY. ANVISA Registration Number: 80102510346 / / / Risk Class: III - High Risk /// Affected Model (s): All models mentioned above. // series: vide portal Anvisa - Alert 2048.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AUTO SUTURE DO BRASIL LTDA; Bellco S.R.L..

¿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
    2049
  • Fecha
    2016-11-18
  • 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
    0
  • Causa
    Hemodialysis device - three events have been reported that resulted in fire on three different machines; during the disinfection cycle of one of the machines and before use in the patient on two machines, which were connected. based on internal investigations at the company bellco srl, it was determined that the battery charge frame would be the source of the problem in two of these events. the source of the problem in the third machine could not be definitively determined because of the magnitude of the damage in the frame, although the available evidence is consistent with the other two events. the manufacturer has found that disconnecting the battery charging frame eliminates the possibility of failure mode while a permanent solution is being implemented.
  • Acción
    Risk classification: III.///Classification of the field action: Update, correction in the field. Update, field correction and subsequent recall, where the products will be exported to Memphis later. / / Field action code: AC05 /// Recommendations to users and patients: The applicable Shares are described in Attachments A, B and C issued by the manufacturer and may be carried out by the technician of the acquiring company or through the Technical Assistance of MEDNEX BRASIL, Rua Sampaio Viana, 277 - 9 ° andar, CEP 04004-000 - Paraíso, São Paulo - SP, Phone: + 55 11 2039-1330 company is authorized and trained by the manufacturer Bellco.

Device

Trade name: HEMODIALISE BELLCO MACHINE /// Medical Product Model: FORMULA 2000, FORMULA 2000 PLUS...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Bellco S.R.L.
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA