Events

Alerta De Seguridad O Notificaciones De Seguridad para Plum 360 infusion pumps

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 ICU Medical.

¿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
    2018-02-15
  • Fecha de publicación del evento
    2018-02-15
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/plum-360-infusion-pumps-user-actions-required-to-prevent-risk-of-interrupted-infusion-or-delay-to-treatment
  • 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
    Manufactured by icu medical (formerly hospira) – potential for connectivity engine module to disengage from main chassis, which may lead to power down without an alarm (mda/2018/006).
  • Acción
    Identify affected pumps, which were manufactured from 29 April 2015 to 25 October 2016 inclusive – see the spreadsheet listing device serial numbers which accompanies this Medical Device Alert and the manufacturer’s Field Safety Notice (FSN). If you are still unsure, contact the manufacturer. Inspect affected pumps as detailed in the FSN. If a loose connectivity engine module or blank display is found, remove the pump immediately from service, and contact manufacturer for repair. If the pump powers down without an alarm, use an alternative pump, and contact manufacturer for repair. Assist manufacturer to schedule appointments for inspection/repair and ensure pumps are made available to manufacturer for inspection/repair at the scheduled time/date. Ensure you have read the Field Safety Notice and have completed and returned the acknowledgement form as currently the manufacturer has not received sufficient responses

Device

Plum 360 infusion pumps
  • Modelo / Serial
  • Descripción del producto
    The manufacturer provided a customised list of serial numbers with the FSN in June 2017. To identify affected devices either refer to the customised list, or review the attached spreadsheet below.
  • Manufacturer
    ICU Medical

Manufacturer

ICU Medical
  • Dirección del fabricante
    ICU Medical Customer Service Tel: 020 3357 9400
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    MHRA