Events

Retiro De Equipo (Recall) de Smart Site Add-on Bag Access Device

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-01631-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-16
  • 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-01631-1
  • 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
    Reports have been received of leakages between the spike port and the drip chamber spike of the smart site add-on bag access device. separation and leakage between the spike port and the drip chamber spike may occur during infusion. to date, there have been no reports of serious injury or death in australia associated with the separation or leaks.
  • Acción
    CareFusion is advising customers to quarantine affected stock. Customer Service will then arrange for the pick-up of the affected stock and issue a replacement or an account credit.

Device

Smart Site Add-on Bag Access Device
  • Modelo / Serial
    Smart Site Add-on Bag Access Device Model Number: 10013365 Lot Numbers: 15055702, 15056299, 15056618, 15065645, 15075740, 15077085, 15085031, 15086107, 15095014, 15095411, 15106928, 15116928, 15126069, 15127413, 16015324, 16015607ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd