Events

Retiro De Equipo (Recall) de ARCTIC SUN 5000 Temperature Management System (220-240 V Australia)

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-2017-RN-00534-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-19
  • 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-00534-1
  • 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 issue regarding the use of the arctic sun 5000 temperature management system, in excess of 2,000 system hours, without conducting preventative maintenance has been identified. this issue may result in failure of certain components, in particular, the mixing pump of the system. the mixing pump runs continuously during operation and its failure may cause the system to cease functioning as intended. therefore, resulting in no availability of cooling or rewarming therapy for the patient. to date, bard australia has not received adverse reports of injuries or diseases related to this issue.
  • Acción
    Bard Australia is updating the Operators Manual and the Service Manual for the ARCTIC SUN 5000 Temperature Management System. Customers are advised to examine their inventory for affected devices to determine their total system hours of use by following the instructions detailed in the recall letter. Customers with devices approaching or exceeding 2,000 system hours are requested to contact their local Bard representative for further information. Customers with devices that have less than 2,000 hours are reminded to address potential issues before their occurrence in order to maintain device availability. In the event of a device failure, customers are advised to utilise alternative conventional methods for patient temperature control.

Device

ARCTIC SUN 5000 Temperature Management System (220-240 V Australia)
  • Modelo / Serial
    ARCTIC 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