Events

Retiro De Equipo (Recall) de Animas Insulin Infusion Pump (ambulatory insulin 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 Australasian Medical & Scientific 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-00690-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-07-20
  • 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-00690-3
  • 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
    Some patients experienced gradual wear of their insulin pump keypad that led to damage such as tearing or peeling of the edge of the keypad from the insulin infusion pump. the buttons may not respond as intended. the potential hazard is that it may cause the pump to malfunction and may cause under infusion or over infusion of insulin, resulting in hyperglycaemia or hypoglycaemia respectively.
  • Acción
    Customers are requested to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of inspecting the pump. The Sponsor will replace any pumps that have a confirmed issue with the keypad.

Device

Animas Insulin Infusion Pump (ambulatory insulin infusion pump)

Manufacturer

Australasian Medical & Scientific Ltd