Events

Retiro De Equipo (Recall) de HEARTMATE II LVAS - SYSTEM CONTROLLER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ABBOTT MEDICAL CANADA INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    121776
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-03-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    As follow-up to the most recent communication in september 2015we are advising health canada that thoratec corporation acquired by abbott laboratories is updating its alert guides conducting a software upgrade and adding controller alignment markings for the heartmate ii system controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations. the current updates include: - updated labeling and alarm guides which will be provided by an abbott representative and included with the system controller packaging. - a software upgrade that simplifies the system controller alarm messaging by removing some advisory alerts on the patient's system controller. these are non-critical alerts that will be seen by clinicians on the system monitor when patients come in for their next appointment. removing these advisory alerts from the system controller will further reduce the chance that a patient will react to such an alert by attempting to change system controllers unnecessarily. - enhanced connector alignment markings on the system controller and the lvad's driveline connector to provide clearer aids in aligning the connectors during insertion/removal. o the system controller with new yellow markings will be provided to all new patients and those current patients with a replacement of the system controller. o some existing patients will need to have their controller replaced (i.E. damaged or old model controller). in these cases we will replace the controller at no cost however in such a case the patient's implanted driveline will not be changing and will not have matching yellow markings.

Device

HEARTMATE II LVAS - SYSTEM CONTROLLER
  • Modelo / Serial
    Model Catalog: 106762 (Lot serial: ALL); Model Catalog: 106015 (Lot serial: ALL)
  • Descripción del producto
    HEARTMATE II LVAS-SYSTEM CONTROLLER;HEARTMATE II LVAS-IMPLANT KIT
  • Manufacturer
    ABBOTT MEDICAL CANADA INC.

Manufacturer

ABBOTT MEDICAL CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • 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
    HC