Events

Retiro De Equipo (Recall) de HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Heartware Pty Ltd.

¿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
    RC-2013-RN-01323-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01323-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Subsequent to a urgent recall for product correction (tga ref: rc-2013-rn-00126-1) of hvad pump's driveline connector housing become partially or fully separated from the front portion of the driveline connector, heartware have identified an alternative failure mechanism. in 8 cases, customers have reported that the locking mechanism of the driveline connector has failed to engage. there have been no reports of injury. heartware has made changes to the manufacturing procedures to address this issue.
  • Acción
    Heartware is advising users that should the driveline disconnect from the controller, push the driveline connector back into the controller immediately and contact Heartware for repair.. Heartware is advising clinicians to inspect patient's driveline connector as described in the provided technical bulletin for proper locking. For already implanted patients, please arrange a follow up visit at the earliest convenience to check the patient's driveline connector. If the locking mechanism of the driveline connector is found to have failed to engage, please push the connector back into the controller and contact Heartware for repair.

Device

HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in p...
  • Modelo / Serial
    HeartWare Ventricular Assist System (intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end stage heart failure)Catalogue Numbers: 1100, 1101, 1102, 1103, 1104 & 1205Serial Numbers: HW001 to HW11215 and HW20001 to HW20296ARTG Number: 181875
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Ltd

Manufacturer

Heartware Pty 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
    DHTGA