Events

Retiro De Equipo (Recall) de FOLFusor SV 0.5 ml/hr

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-2014-RN-00447-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-17
  • 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-2014-RN-00447-1
  • 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 direction insert for the folfusor sv 0.5 ml/hr states that infusion rates may be up to 10% greater than the nominal infusion rate of 0.5 ml/hr. flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal infusion rate.
  • Acción
    Baxter is notifying their customers that infusion rates may be higher and could result in a 15% greater than nominal infusion rate rather than 10% as stated in the IFU. Baxter is also reiterating the factors that can contribute to over infusion. These factors along with the 15% flow rate accuracy could result in infusion rates in excess of 30% greater than the nominal flow-rate. Baxter is currently investigating options to bring the flow rate into specification.

Device

FOLFusor SV 0.5 ml/hr
  • Modelo / Serial
    FOLFusor SV 0.5 ml/hrProduct Code: 2C4700KAll lot numbers up to and including 14B039ARTG Number: 168893
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd