Events

Retiro De Equipo (Recall) de CADD- Solis Ambulatory Infusion Pumps

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-2015-RN-00447-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-28
  • 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-2015-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
    Smiths medical has become aware of an issue with an intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding of the cassette/ keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set “disposable” to the pump. when binding occurs, it can prevent the key from fully rotating the cassette/ keypad lock to the locked (engaged) position. to start an infusion with cadd-solis pump models 2111(grey keypad) and 2112 (yellow keypad), and model 2120 (vip), when in pca mode, the lock must be fully engaged. cadd-solis pump model 2120 will start in all other delivery modes without the cassette/ keypad lock being engaged.Smiths medical has received no reports of serious injury or death related to this issue.
  • Acción
    Smiths Medical has resolved the problem associated with the binding of Cassette/ Keypad Locks and implemented a lubrication step during manufacture and during servicing at Smiths Medical Authorised Service Centres. A customer service representative will contact users to arrange for repair of their CADD-Solis Pumps. This action has been closed-out on 08/08/2016.

Device

CADD- Solis Ambulatory Infusion Pumps
  • Modelo / Serial
    CADD- Solis Ambulatory Infusion Pumps Model Numbers 2111, 2112, and 2120Serial Numbers: 1061043 through 1067598 ARTG Number: 109467
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd