Events

Alerta De Seguridad O Notificaciones De Seguridad para Receptal 1 litre canisters, 1 litre PVC liners, 1 litre PE liners

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 Hospira (formerly manufactured by Abbott).

¿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
  • ID del evento
    MDA/2013/048
  • Número del evento
    CON289464
  • Fecha
    2013-07-02
  • Fecha de publicación del evento
    2013-07-02
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON289464?tabName=allTabs
  • 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
    Potential loss of suction. hospira has issued an updated field safety notice (dated 7 june 2013) to extend the recall of 1 litre devices to those marked with abbott labels, and to instruct customers to seek alternatives.  this mda is an extension of mda/2013/026 published in may 2013 to include these additional devices. the vacuum needed to generate the suction cannot be created if the hard canister and the single-use liner are not properly seated during use, or if the liner separates from the canister during use. hospira has not yet identified the root cause of this failure.  an investigation is ongoing. hospira cannot guarantee that the pre-use checks (listed below) will identify all defective units.  therefore, a unit could pass the pre-use checks and still fail during use. hospira is unable to trace customers who purchased products marked with abbott labels.
  • Acción
    Identify affected devices. Ensure that users are aware of the manufacturer’s updated Field Safety Notice. Seek alternative devices immediately and return affected devices to the manufacturer. Until alternative devices are available: Perform pre-use checks (see below).  If defective units are identified, remove from use. Exercise caution in use, as failure can occur despite the pre-use checks. Ensure that a back-up suction device is available at all times. Until alternatives are made available, the following pre-use checks must be carried out: During assembly, check the underside of the liner lid to ensure that the liner is not misaligned and there is a flush connection. Verify that the correct vacuum pressure can be achieved and that there is no loss of suction.

Device

Receptal 1 litre canisters, 1 litre PVC liners, 1 litre PE liners
  • Modelo / Serial
  • Descripción del producto
    Update to MDA/2013/026 Recall of Hospira 1 litre suction canisters and liners - additional products recalled. Suction canisters and liners with Abbott labels and list numbers are now included in the recall. One litre suction canisters - Abbott list number 770462. One litre suction liners - Abbott list numbers L212A52 and L213A52. All batch numbers are affected. The affected products are part of a closed, disposable suction system that is used to isolate suction waste.  They are used for adult, paediatric and neonatal patients. Hospira has issued an updated Field Safety Notice (dated 7 June 2013) to extend the recall detailed in MDA/2013/026 , to include 1 litre devices supplied under the legacy Abbott model numbers. The Abbott labelled products are no longer in production, but may still be in stock. The Abbott and Receptal products are manufactured to the same design and both are, therefore, affected.  To clarify, the full list of devices affected by this problem is: Receptal 1 litre canisters (List number 43449), previously marketed as Abbott 1L suction canisters (List number 770462) Receptal 1 litre PVC liners (List number OL212), previously marketed as Abbott 1L suction liners (List number L212A52) Receptal 1 litre PE liners (List number OL213), previously marketed as Abbott 1L suction liners (List number L213A52).
  • Manufacturer
    Hospira (formerly manufactured by Abbott)

Manufacturer

Hospira (formerly manufactured by Abbott)
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    MHRA