Events

Retiro De Equipo (Recall) de Epidural Minipack Systems (Epidural anaesthesia kit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smiths Medical Australasia 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-2013-RN-01154-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-08
  • 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-2013-RN-01154-1
  • 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
    The manufacturer is updating the instructions for use (ifu) for users should they experience difficulties removing the catheter during procedure.The wording in the current ifu states: "if resistance is felt upon withdrawal, consult current medical literature for specific techniques". this is to be replaced by: "if resistance is felt or if the catheter stretches excessively on withdrawal, cease removal. never exert excessive force as this may compromise the integrity of the catheter. if clinically appropriate, reposition the patient (flex or extend, sit up or lay down) and slowly withdraw the catheter. if further resistance, repeat step and/or allow the patient to relax for several minutes/hours and attempt to remove later. if unable to remove, consult the anaesthetist. after removal, examine the catheter to ensure that the entire catheter with tip is intact. should the top not be intact, consult the anaesthetist".
  • Acción
    Smiths Medical is providing users with updated Instructions for Use (IFU) which includes the updated instructions.

Device

Epidural Minipack Systems (Epidural anaesthesia kit)

Manufacturer

Smiths Medical Australasia Pty Ltd