Events

Retiro De Equipo (Recall) de Clearlink System Solution Set (Infusion administration set)

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-2013-RN-00741-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-07-19
  • 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-00741-1
  • 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 anz received feedback from a customer that an iv tube could not be loaded into an infusion pump because the slide clamp was not correctly assembled. baxter facility received the complaint sample and confirmed the slide clamp had been assembled in the reverse direction. the incorrect assembly would lead to incorrect direction of infusion such that blood may be withdrawn from a patient and result in acute blood loss and/or delay in treatment of life sustaining medication as a worse case scenario.
  • Acción
    Baxter Healthcare are advising customers to remove affected product from use and return to Baxter for credit.

Device

Clearlink System Solution Set (Infusion administration set)
  • Modelo / Serial
    Clearlink System Solution Set (Infusion administration set)Product Code: FNC3110Lot Numbers: SR13A04021, SR13A02041, SR13A07032 (Expiration date: Jan 2018), SR13B14077 (Expiration date: Feb 2018)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd