Events

Alerta De Seguridad para Product Affected by Field Action: SynchroMed II Deployable Infusion Pump (Registration 10339190229) Models 8637-20, 8637-40 - Risk Class IV. DISTRIBUTION MAP IN ANNEX.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA; MEDTRONIC INC..

¿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
    1835
  • Fecha
    2016-02-29
  • 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, the customer must "Identify SynchroMed II pumps manufactured prior to project changes through product identification number and expiration date. According to the following information: Product Identification Number for pumps manufactured before design changes: • Model 8637-20: PIN 863702007H • Model 8637-40: PIN 863704007H Any pump with an Expiration Date on or before May 14, 2017 was manufactured prior to design changes. Wait for the Medtronic Representative to contact you for equipment recovery. "
  • Causa
    Medtronic has incorporated enhancements to the synchromed ii pump, which reduces the possibility of an internal short circuit and motor corrosion, resulting in less effective treatment. currently all synchromed ii pumps are already manufactured with these improvements. the statement is intended to inform customers that medtronic representatives will, through each customer's inventory review, retrieve any out-of-use synchromed ii pumps manufactured before design changes with the above improvements.
  • Acción
    The company will carry out field corrections. LETTER TO THE CUSTOMERS IN ANNEX. Code FA696.

Device

Product Affected by Field Action: SynchroMed II Deployable Infusion Pump (Registration 1033919022...

Manufacturer

MEDTRONIC COMERCIAL LTDA; MEDTRONIC INC.
  • 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