Alerta De Seguridad para LVAS Left Ventricular Assist System HEARTMATE II

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Thoratec Corporation.

¿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
    I1703-115
  • Número del evento
    2013DM-0009667
  • Fecha
    2017-03-30
  • País del evento
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer informs that it has initiated actions to reduce adverse events presented by the exchange of the controller by patients, since said actions are best carried out by medical professionals in a controlled environment.

Device

  • Modelo / Serial
  • Clasificación del producto
  • Descripción del producto
    It is a rotational left ventricular axial flow assist system and can generate flows of up to 10 liters per minute (LPM) attached to the apex of the left ventricle and the ascending aorta, blood labomba HEARMATE II diverts the blood from the weakened left ventricle and pushes it towards the rest of the body. The controller of the system, through its internal software program regulates the pumping.
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA