Events

Alerta De Seguridad O Notificaciones De Seguridad para Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Smiths Medical CADD.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2018-06-20
  • Fecha de publicación del evento
    2018-06-20
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/smiths-medical-cadd-non-flow-stop-medication-cassette-reservoirs-recall-of-specific-lots-due-to-risk-of-under-delivery-of-medication
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Smiths medical cadd® non flow-stop medication cassette reservoirs may have been manufactured with an incorrect pressure plate which could cause partial or total occlusion of the tubing with no alarm.
  • Acción
    Refer to the manufacturer’s Field Safety Notice (FSN) for a list of affected product codes and the attached spreadsheet for a list of affected lots Identify, stop using and quarantine these devices Contact Stericycle to return the devices as directed in the manufacturer’s FSN

Device

Smiths Medical CADD® Non Flow-Stop Medication Cassette Reservoirs
  • Modelo / Serial
  • Descripción del producto
    CADD® Medication Cassette Reservoirs are intended for ambulatory volumetric infusion of small doses (up to 50ml,100ml, or 250ml), and are designed to be used with a variety of CADD ambulatory infusion pumps (except CADD-Micro™, CADD-MS® 3 and CADD-TPN® pumps).In addition to the Field Safety Notice which details affected products, please refer to the spreadsheet which accompanies this MDA for additional unique device identification information, and models and lot numbers.
  • Manufacturer
    Smiths Medical CADD

Manufacturer

Smiths Medical CADD
  • Dirección del fabricante
    Smiths Medical Tel: 01233 722 227Email: fieldactions@smiths-medical.comStericycleEmail: smithscadd101@stericycle.com
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    MHRA