Events

Retiro De Equipo (Recall) de Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic drugs)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare 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-2015-RN-01070-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-03
  • 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-2015-RN-01070-1
  • 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
    Baxter healthcare has received reports of leaks at the spike's air vent subassembly.A leak in a paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. if not detected during priming or initial set up, this may lead to serious adverse health consequences. this leak may also result in potential skin contact which would result in potential skin irritation.
  • Acción
    Baxter Healthcare is advising users to inspect and quarantine any affected stock for return to Baxter. This action has been closed-out on 31/08/2016.

Device

Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic d...
  • Modelo / Serial
    Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic drugs)Product Code: MMC9627SLot Number: 14H13V434ARTG Number: 108526
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd