Events

Retiro De Equipo (Recall) de Maquet Heater-Cooler Unit HCU 40

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-00904-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-24
  • 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-00904-1
  • 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
    Maquet cardiopulmonary has developed and validated new and revised cleaning and disinfection procedure for hcu 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all hcu 40 systems in the field.This update also includes the following actions:1. replacement of valves:existing valves will be replaced by successors with proven material compatibility with the new cleaning and disinfection procedure;2. replacement of flow sensors:in hcu 40 devices with serial number below 90440266 the mechanical flow sensor will also be replaced by its successor to ensure material compatibility with the new cleaning and disinfection procedure; and3. software update release 1.2.3.0:hcu 40 devices will be updated with the new software (release 1.2.3.0) including a new cleaning wizard guiding the user through the new cleaning and disinfection process step by step.
  • Acción
    Actions to be taken by users: 1. The update on HCU 40 systems has to be performed by authorised Maquet service personnel according to the Update Instruction as soon as possible; 2. Fill out the supplied Acknowledgement Form and return it as soon as possible to your local Maquet representative; 3. Incorporate the new cleaning and disinfection procedures into operating processes, and conduct any necessary training; 4. Continue to monitor the hygiene (contamination levels) in accordance with internal practices; and 5. Immediately report any contamination findings to the local Maquet representative by filing a complaint.

Device

Maquet Heater-Cooler Unit HCU 40
  • Modelo / Serial
    Maquet Heater-Cooler Unit HCU 40All Serial Numbers below 90441000ARTG Number 144010
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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