Events

Retiro De Equipo (Recall) de HOTLINE Fluid Warming Sets

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-2014-RN-00344-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-18
  • 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-2014-RN-00344-1
  • 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
    Smiths medical has become aware of an issue with a limited number of warming sets with the potential for leakage form the injection port at the top of the warming set. if fluid leaks at the injection port, the leak is readily detectable by the clinician who would stop using the warming set and obtain a replacement. this could present a minor delay in therapy while a replacement warming set is obtained.
  • Acción
    Smiths Medical is requesting their customers to segregate all affected units. Upon confirmation of the location of affected units a service representative will arrange for the exchange of unused warming sets. This action has been closed-out on 31/08/2016.

Device

HOTLINE Fluid Warming Sets

Manufacturer

Smiths Medical Australasia Pty Ltd