Events

Retiro De Equipo (Recall) de CADD Legacy 1, Model 6400 Ambulatory Infusion Pump

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smiths Medical Australasia 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-2017-RN-01440-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-11-27
  • 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-2017-RN-01440-1
  • 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
    Smiths medical became aware that a number of cadd legacy 1, model 6400 ambulatory infusion pumps, may contain non-matching serial numbers. specifically, the label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump. the non-matching serial number issue does not impact the functionality of the infusion pumps. the risk to patient health as a result of this issue is negligible.
  • Acción
    Smiths Medical is advising users to determine if the serial number on the back of the pump matches the electronic serial number programmed into the pump. If the serial numbers do not match, the pumps are to be returned to Smiths Medical.

Device

CADD Legacy 1, Model 6400 Ambulatory Infusion Pump
  • Modelo / Serial
    CADD Legacy 1, Model 6400 Ambulatory Infusion Pump Product Number: 21-6400-51Serial Numbers: 410006, 410007, 410008, 410009, 410010, 410011, 410012 ARTG Number: 109467
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd