Events

Retiro De Equipo (Recall) de Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences 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-00675-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-02
  • 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-00675-1
  • 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
    During inspection of some distributed rigid suction wands (model s099), edwards discovered plastic particulate inside the sterile pouch and within the internal diameter of the rigid suction wands. the particulate ranged from 0.26 to 0.41 (6.6 to 10.4mm) in size. particulate not detected during the preparation of the device may pose a risk as it may enter into the pericardium and could cause abrasions to the surface of the heart.
  • Acción
    Customers are asked to quarantine the affected product from inventory and return all affected stock with remaining shelf life to Edwards. Customers are asked to contact Edwards customer service or sales representative about alternative suction wand product's availability.

Device

Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid...
  • Modelo / Serial
    Edwards Lifesciences Suction Wand (Used during cardiac surgery for the suction of excessive fluid from the pericardium)Model code: S099All lot numbers ARTG number: 154578
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd