Events

Retiro De Equipo (Recall) de Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-2016-RN-01290-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-30
  • 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-2016-RN-01290-1
  • 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
    An additional warning is to be included in the operator's manual with the advice that the arctic sun temperature management system is not to be used in the operating room environment. this is to address concerns regarding the potential for non-tuberculous mycobacterium (ntm) bacterial transmission to a patient based on use of the device in operating rooms and sterile fields under existing labelling. the probability of harm to a patient is considered remote.
  • Acción
    Bard is providing customers with operator's manual addendum which contains the additional warning that the Arctic Sun Temperature Management System is not intended for use in the operating room environment.

Device

Arctic Sun Temperature Management System (used for regulating the temperature and circulation of ...
  • Modelo / Serial
    Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)Arctic Sun 2000 Temperature Management System (230VAC)Product Code: 2000-03Arctic Sun 5000 Temperature Management System (220-240 V Australia)Product Code: 5000-01-03ARTG Number: 150422
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd