Events

Retiro De Equipo (Recall) de Getinge 46-Series Washer Disinfector with PACS 300/350

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge 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-2015-RN-00174-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-03-12
  • 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-2015-RN-00174-1
  • 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
    The manufacturer has received complaints in germany regarding sediment residuals in the manifold of the washer and disinfector of getinge 46-series (cm302) with pacs 300/350 control.The potential risk is that during the drying phase the air circulating may transport particles from the sedimentation and deposit it on goods. if the particle contains bacterial flora there is the risk of cross contamination.The problem has been identified as insufficient water flow throughout the manifold due to formation of air-pockets where sedimentation may occur. the use of detergents that are not recommended might also have negative impact.No serious injury has been reported in any of the known cases.
  • Acción
    Getinge will contact customers to carry out a modification that will permanently mitigate the risk of this issue occurring in the future. In the interim customers are advised to perform a visual check of all washed items after removal from the washer. Items should be re-washed if any particles are observed. This action has been closed-out on 1/06/2016.

Device

Getinge 46-Series Washer Disinfector with PACS 300/350

Manufacturer

Getinge Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA