Events

Retiro De Equipo (Recall) de Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL

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-01299-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-10-17
  • 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-2017-RN-01299-1
  • 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 that certain non-flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. this product is designed without an arch, but the defective product has a plate with an arch.There is a risk that under delivery of medication may result from the tubing becoming partially or completely occluded when the cassette is attached to the pump. the clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion.
  • Acción
    Smiths Medical is advising users to quarantine remaining stock of the affected product for return for credit. It is recommended that users transition to an equivalent flow stop version of the CADD Medication cassettes.

Device

Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL
  • Modelo / Serial
    Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL50mL CADD Medication CassetteItem Code: 21-7001-24100mL CADD Medication CassetteItem Code: 21-7002-24 100mL CADD Medication Cassette, YellowItem Code: 21-7100-24Multiple Lot Numbers ARTG Number: 145297
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd