Events

Alerta De Seguridad para PRODUCT: Double Catheter Lumen for Hemodialysis PALINDROME HSI //// REGISTRATION: 10349000341 //// RISK CLASS 4 (Maximum Risk) //// MODELS :. 8888145048; 8888145049; 8888145050; 8888145057 //// LOTS (See ANNEX)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DAUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC.

¿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
    1572
  • Fecha
    2015-05-11
  • 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
    According to the company: "PATIENTS WHO HAVE CURRENTLY HAVE THE IMPLANTED DEVICE DOES NOT PRESENT ADDITIONAL RISK THROUGH THIS CONDITION."
  • Causa
    Tests performed by emprea suggest that affected products can not meet the minimum silver release specification for the entire 30 day period. the silver eliminated by the shelter has the purpose of reducing microbial colonization on the catheter surface and subcutaneous tunnel treatment. the results of the tests show that the release of silver initially meets the specification, but, after the nine day, the release of silver continues in reduced level. patients who have current device have no additional risk as to the condition. medtronic has not received adverse effects related to this problem.
  • Acción
    Company sent letter to customers (distribution chain) (See APPENDIX) informing about the Pickup and Return of the product - Action Pickup / Return to the manufacturer - Code: PALINDROME

Device

PRODUCT: Double Catheter Lumen for Hemodialysis PALINDROME HSI //// REGISTRATION: 10349000341 ///...

Manufacturer

DAUTO SUTURE DO BRASIL LTDA.; COVIDIEN LLC
  • 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