Events

Notificaciones De Seguridad De Campo acerca de HeartMate 3™ Left Ventricular Assist System

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Abbott.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-05-18
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Abbott has observed cases in which the outflow graft bend relief (ogbr) on the heartmate 3 (hm3) left ventricular assist system (lvas) was not fully and evenly secured to the outflow graft. as a result, we conducted an internal review of x-rays from both the u.S. momentum 3 ide and continuous access protocol (cap) studies, and identified additional cases where the ogbr was not properly secured. at this time, we are providing you this letter to notify you of updated patient management recommendations and a new training to reinforce the ogbr connection technique described in the hm3 lvas instructions for use (ifu). .

Device

HeartMate 3™ Left Ventricular Assist System
  • Modelo / Serial
    # 106524INT 105581INT – Packaged assembly Outflow, HM3(INT)
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • 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
    AMPMDRS