Events

Alerta De Seguridad para PARADIGM QUICK SET MEDTRONIC INFUSION CATHETER - ANVISA Record: 10339190272. Model: MMT-397 - Lot 8200442.

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..

¿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
    969
  • Fecha
    2009-07-20
  • 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
    See attachments.
  • Causa
    Paradigm quick set infusion catheter unexpected behavior at the time of the prime manual associated with the saturation of the p-cap opening membrane with silicone oil and therefore not allowing air to escape from the reservoir compartment can prevent ventilation of the pump of insulin, potentially resulting in excess or lack of insulin to be delivered, leading to serious injury or death.
  • Acción
    The actions recommended to the users of the product are as follows: (1) Immediate interruption of the use of infusion kits of this lot; (2) Switch to an infusion kit that has not been affected or implement the injection contingency plan established with your physician; (3) Contact your supplier to arrange for the return and replacement of any Quick Set "Batch 8" infusion kits at no additional charge.

Device

PARADIGM QUICK SET MEDTRONIC INFUSION CATHETER - ANVISA Record: 10339190272. Model: MMT-397 - Lot...

Manufacturer

Medtronic Comercial Ltda.
  • 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