Events

Retiro De Equipo (Recall) de HS66 Turbo LTSF Steriliser

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-2014-RN-00908-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-18
  • 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-00908-1
  • 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 problem identified indicates a leakage at a critical valve due to clogging of solidified formalin solution, also known as paraformaldehyde. this leakage might affect the efficacy of the ltsf sterilisation cycle and cause potential non-sterility. the problem appears stealthy until clogging has reached the level where the built-in leakage monitoring system of the steriliser is able to indicate leakage and cause an alarm. the potential risk caused by clogging is that sterile filtered air can be introduced into the sterilizer chamber during the sterilization cycle and may partially block penetration of formaldehyde at items subjected to sterilization. the risk for non-sterility is assessed to increase at hollow instruments compared to solid instruments.
  • Acción
    A Getinge representative will schedule a service technician visit to inspect, clean and take preventive measures at your sterilizer for the problem not to reappear. In the meantime all users are advised to take precautions as follows: - Depending of the occurrence and frequency of LTSF sterilization at your sterilization department use biological indicators for monitoring the sterilization efficacy at a daily or weekly basis; - When growth is indicated by biological indicators - stop using the sterilizer and contact your Getinge representative for prompt assistance. This action has been closed-out on 03/06/2016.

Device

HS66 Turbo LTSF Steriliser

Manufacturer

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