Events

Retiro De Equipo (Recall) de Softpac C299 (used in preparing dialysate for haemodialysis therapies)

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-2016-RN-00815-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-17
  • 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-2016-RN-00815-1
  • 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
    Two complaints were received from customers that bags labelled as containing softpac c295 were found in boxes labelled as containing softpac c299. after investigation, baxter determined that the bags labelled as containing softpac c295 actually contained softpac c299 solution. the softpac c295 and c299 formulations have the same composition except for the calcium (ca+) and chloride (cl-) content. the labelling error may lead to electrolyte imbalances, under circumstances of repetitive use of mislabelled product. no reports of related adverse events have been received by baxter.
  • Acción
    Baxter is advising users to remove the affected product from use. Affected product will be replaced with unaffected stock. This action has been closed-out on 15/02/2017.

Device

Softpac C299 (used in preparing dialysate for haemodialysis therapies)
  • Modelo / Serial
    Softpac C299 (used in preparing dialysate for haemodialysis therapies)Product Code: 114667Lot Number: 755756Expiry Date: 30 April 2017ARTG Number: 146875
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd