Events

Retiro De Equipo (Recall) de 3M Bair Hugger Full Access Underbody Blanket

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por 3M 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-2018-RN-00102-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-06
  • 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-2018-RN-00102-1
  • 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
    3m recently became aware that a design change to the bair hugger full access underbody blanket, models 63500, can make them more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use. the health risk associated with this issue is if blankets are only partially inflated during use in surgery, it could result in incomplete warming therapy. loss of therapy may lead to in advert perioperative hypothermia. this recall does not affect any other lots of 3m bair hugger full access underbody blanket.
  • Acción
    3M is advising users to inspect inventory and quarantine affected stock of the specified lot numbers immediately to prevent further use. 3M will be in contact with users to arrange collection of affected stock.

Device

3M Bair Hugger Full Access Underbody Blanket
  • Modelo / Serial
    3M Bair Hugger Full Access Underbody BlanketModels 63500Manufactured between: 2nd October 2017 - 20th November 2017Lot Numbers: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366Product Code: 70200791203ARTG Number: 218944
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    DHTGA