Events

Retiro De Equipo (Recall) de HICO - Variotherm 550 Hypothermia/Hyperthermia Unit

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-2016-RN-01600-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-13
  • 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-2016-RN-01600-1
  • 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
    It has come to the attention of maquet australia that the hico-variotherm 550 hypothermia/hyperthermia unit has been supplied under the incorrect intended purpose of heat exchange control unit for extra corporeal membrane oxygenation. as described in the operating instructions document supplied with the device, the variotherm is solely intended for the cooling or heating of water mats used to cool or warm a patient. utilising the variotherm for heat exchange control across a gas exchange membrane in extra corporeal membrane oxygenation (ecmo) is against the intended use of the device and is incompatible with maquet oxygenators due to the associated cleaning procedures outlined in the user manual of the variotherm unit. in particular the germicidal agent (sanosil, hydrogen peroxide) that is recommended to be added to the tank water after the final flush (prior to use) is not suitable for use with maquet oxygenators.
  • Acción
    Customers are advised to ensure that the intended purpose as indicated in the user manual is being complied with at their facilities. Maquet is offering to replace the Variotherm with units with an ECMO indication and customers are advised to contact their Maquet representative to arrange the replacement, if needed.

Device

HICO - Variotherm 550 Hypothermia/Hyperthermia Unit
  • Modelo / Serial
    HICO - Variotherm 550 Hypothermia/Hyperthermia UnitPrevious ARTG number: 265557
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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