Events

Retiro De Equipo (Recall) de Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fresenius Kabi Australia 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-01324-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-23
  • 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-01324-1
  • 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
    Fresenius kabi has identified a failure involved with the power adapter. in some cases a spark or short circuit has been reported on the wall socket used to connect the curlin 6000 and painsmart pumps. this failure does not affect the pump itself.
  • Acción
    Fresenius Kabi is replacing all affected adapters with an improved adapter. In the meantime to mitigate any risk of injury customers are advised to use the device on the battery power and not use the adapter. The adapter is optional and is required only if the pump is to run on AC mains. Hence the pump can be used without the adapter.

Device

Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory
  • Modelo / Serial
    Curlin 6000 Painsmart IOD Infusion Pump Power Adapter AccessoryUsed with: Moog Curlin 6000 Ambulatory Infusion Pump and Moog Painsmart IOD Infusion PumpARTG Number: 225964 (Fresenius Kabi Australia Pty Limited - Infusion pump, analgesic, patient-controlled)
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd