Events

Retiro De Equipo (Recall) de ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Administration sets for the infusion of intravenous solutions and blood)

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-2012-RN-00918-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-09-07
  • 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-2012-RN-00918-1
  • 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 has received complaints for the buretrol ball-valve products with reports of air travelling below the ball-valve in the drip chamber and into the tubing. the ball-valve component is designed to prohibit the flow of air from the burette into the tubing as the burette is emptied. upon further investigation baxter has determined that the ball-valve feature may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
  • Acción
    Baxter is recalling all affected sets and replacing it with unaffected product codes.

Device

ClearLink System BURETROL Solution Set with 150ml ClearLink Burette (Ball-Valve Drip Chamber) (Ad...

Manufacturer

Baxter Healthcare Pty Ltd