Events

Alerta De Seguridad para Select 3D and Select CAP Arterial Cannula

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-02-11
  • Fecha de publicación del evento
    2014-02-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140211b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic select 3d and select cap arterial cannula the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning all models of select 3d and select cap arterial cannula product families manufactured by medtronic due to reports of the cannula body splitting near the suture collar.. the affected model numbers are 78618, 78620, 78622, 78624, 78718, 78720, 78722, cb78722, 78724, 78818, 78820, 78822, 78920, 78922, 78924, 3y90r3 and c300901b. since january 2012, the manufacturer has received nine such reported events which represent a 0.06% occurrence rate. of these, one was associated with a patient death and one other was associated with serious injury. according to the manufacturer, potential patient harms resulting from this type of splitting may include: the delivery of inadequate blood flow, possibly resulting in ischemia or inadequate perfusion. difficulty in inserting/removing the cannula tip, possibly resulting in a procedural delay, vessel damage, dissection or other complications that may contribute to patient death. the manufacturer advises users to identify and quarantine all affected products and return them to the manufacturer. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con371783 according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 february 2014.

Device

Select 3D and Select CAP Arterial Cannula
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Select 3D and Select CAP Arterial Cannula
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH