Events

Alerta De Seguridad O Notificaciones De Seguridad para Riata and Riata ST – all silicone coated models

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 St Jude 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
  • ID del evento
    MDA/2013/027
  • Número del evento
    CON270680
  • Fecha
    2013-05-01
  • Fecha de publicación del evento
    2013-05-01
  • 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/CON270680?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
    Improper use of peritoneal dialysis transfer sets may result in contamination, leading to infection or peritonitis. baxter healthcare ltd issued a field safety notice (fsn) in march 2013 to communicate various changes to the instructions for use (ifu).
  • Acción
    Identify affected devices. Ensure that all staff, who are responsible for placing and maintaining peritoneal dialysis transfer sets, are aware of the manufacturer’s FSN and the changes to the IFU. Ensure that all patients with these devices, who maintain their own transfer set, are aware of the patient advice in the FSN. This includes: the importance of maintaining aseptic technique. the appropriate use of chemical agents. that the use of excessive force can result in damage to the twist clamp. Return the customer reply form in the FSN to the manufacturer. The MHRA has previously issued advice on disinfecting and cleaning reusable medical devices with plastic surfaces to prevent damage.  See MDA/2013/019.

Device

Riata and Riata ST – all silicone coated models
  • Modelo / Serial
  • Descripción del producto
    Implantable cardioverter defibrillator (ICD) leads. Riata and Riata ST – all silicone coated models.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRA