Events

Retiro De Equipo (Recall) de SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia 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-2017-RN-01528-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-19
  • 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-2017-RN-01528-1
  • 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
    Syncardia has updated the freedom driver system manuals and labelling to strengthen existing labelling content with regard to freedom driver drops, rough handling and exposure to liquid/debris. the freedom driver system manuals have been updated as follows: - advising patients to switch from their primary freedom driver to their backup freedom driver in the event their freedom driver is dropped, subjected to rough handling or exposed to liquid/debris. - adding more detailed information regarding the definition of rough handling. - advising hospital clinicians, patients and their caregivers to clean the freedom driver and drivelines only with a cloth lightly dampened with water. - advising hospital clinicians to refresh patient and caregiver training at every clinic visit.
  • Acción
    Device Technologies is providing users with updated manuals.

Device

SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart Sy...
  • Modelo / Serial
    SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)Product Code: SYN-595000-001Supplied through Clinical Trial and SAS Category A
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd