Events

Retiro De Equipo (Recall) de Alaris SmartSite Needlefree Connector

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-2014-RN-00119-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-27
  • 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-00119-1
  • 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
    Carefusion has identified potential risks with model code 2000e and lot numbers listed due to connection issues. the affected smartsite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. leakage may also be observed if the connector disconnects from the female luer during infusion. an inability to disconnect may require replacement of a line.
  • Acción
    Carefusion is requesting users to segregate and return unused stock of connectors with polycarbonate housing to Carefusion. Polycarbonate materials were introduced because they provide more resistance to isopropyl alcohol than the acrylic housing hub. Now that the 2000E polycarbonate version will no longer be available, please remind staff that when accessing the valve, remember to Swab The Hub every time, do not swab the whole body of the device and take care to follow instructions during connection and disconnection of the SmartSite connector.

Device

Alaris SmartSite Needlefree Connector
  • Modelo / Serial
    Alaris SmartSite Needlefree ConnectorModel Number: 2000EBatch Numbers:13106451, 13046117, 13106355, 13045933, 13106754, 13086446, 13106753, 13096012, 13115734, 13095674, 13115872, 13095579, 13105584, 13095237, 13095913, 13106096, 13095914, 13095675, 13096488, 13106260 & 13106497ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd