Events

Alerta De Seguridad para DLPR Single Stage Venous Cannulae

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic International Ltd..

¿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
  • Fecha
    2011-12-20
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111220.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: update of the instructions for use of dlpr single stage venous cannulae medical device manufacturer, medtronic international ltd., is notifying customers that they are in the process of updating the instructions for use of dlpr single stage venous cannulae. medtronic has received two reports of patient deaths due to product failure during use in ventricular assist procedures, which are outside the indications for use. the following statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use: “do not use this product for extended terms such as ventricular assist procedures.” according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for more information.

Device

DLPR Single Stage Venous Cannulae
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Update of the Instructions for Use of DLPR Single Stage Venous Cannulae
  • Manufacturer
    Medtronic International Ltd.

Manufacturer

Medtronic International Ltd.
  • 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
    DH