Events

Alerta De Seguridad para DLP MEDTRONIC AND FEMORAL DLP MEDTRONIC FEMALE DLP MEDTRONIC AND INSERTION KIT. Anvisa registry n ° 10339190179. Models at risk: 57414, 57417, 57421, 96017 and 96021. Affected lots: see Appendix 1 of the Company Alert Message, available at: http://portal.anvisa.gov.br/wps/ wcm / connect / 6e0ea68048e3a8769f349fc758bf9f01 / Letter + to + Customer + - + FA653.pdf? MOD = AJPERES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC PERFUSION SYSTEMS; 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
    1616
  • Fecha
    2015-06-26
  • 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
    Medtronic is initiating a voluntary Recall regarding selected models and batches of DLP® Femoral Cannulas and DLP® Femoral Cannulae and Insertion Kits (containing the affected femoral arterial cannula) due to recent reports in which the user presented difficulty or not was able to connect the cannula to the perfusion circuit tube. See Appendix 1 of the alert message for the affected model and batch numbers. The cannula has a drawing with an elevation in the connector region of the connector which assists in both the sliding of the tube over the burrs and ensures that the tube is once placed in place. Research has confirmed that for specific batches of DLP Femoral Artery, the orientation of the connector burrs is to recede. As a consequence there may be delayed or prolonged procedure, trauma to the patient's vasculature or loss of blood (consequences hitherto not recorded in any report involving the product).
  • Causa
    User may have difficulty, or can not, connect the cannula to the perfusion tube.
  • Acción
    Medtronic is collecting the batches at risk of the product. To hospitals and healthcare professionals: immediately identify and keep segregated all listed products not used in your inventory. Return the products to Medtronic - the sales representative of the company should assist you in this regard and also with regard to replacement of the product. Check detailed information at http://portal.anvisa.gov.br/wps/wcm/connect/6e0ea68048e3a8769f349fc758bf9f01/Carta+ao+Cliente+-+FA653.pdf?MOD=AJPERES.

Device

DLP MEDTRONIC AND FEMORAL DLP MEDTRONIC FEMALE DLP MEDTRONIC AND INSERTION KIT. Anvisa registry n...

Manufacturer

MEDTRONIC PERFUSION SYSTEMS; 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