Events

Alerta De Seguridad para MiniMed Sure-T infusion sets

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
    2015-06-11
  • Fecha de publicación del evento
    2015-06-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150611.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 minimed sure-t infusion sets medical device manufacturer, medtronic, has issued a medical device safety alert concerning its minimed sure-t infusion sets. the manufacturer has identified that certain minimed sure-t infusion sets had a slight increase in reports where the steel needle broke during use. in a small number of these reported cases, the needle break led to hospitalization for the management of glucose levels and/or treatment for removal of the needle. since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks. according to the manufacturer, if a needle break occurs, insulin delivery is interrupted and the pump will not alarm to notify users. the interruption of insulin delivery can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis. the manufacturer advises users to consult their healthcare professional if they experience a needle break while the infusion set is inserted. the manufacturer will replace the affected products if needed and advises users to follow the instructions for use carefully if they continue using the affected products. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 june 2015.

Device

MiniMed Sure-T infusion sets
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic MiniMed Sure-T infusion sets
  • 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