Events

Retiro De Equipo (Recall) de Level 1 Fast Flow Fluid Warmers with and without Air Detection

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smiths Medical Australasia 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-00091-2
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-31
  • 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-00091-2
  • 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
    A limited number of fluid warmers were manufactured with an incorrect printed circuit board component which could prevent the fluid warmer from functioning as intended and also potentially exhibiting a false over temperature alarm.
  • Acción
    Smiths Medical Australasia is requesting users to identify any affected units and place in quarantine. A Biomedical Technician will inspect devices to determine if they are affected and provide a correction.

Device

Level 1 Fast Flow Fluid Warmers with and without Air Detection
  • Modelo / Serial
    Level 1 Fast Flow Fluid Warmers with and without Air Detection Item Code: H-1200Affected Serial Numbers: S103A00028, S103A00029, S103A00094 and S103A00095ARTG Number: 108420
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd