Events

Alerta De Seguridad para TRELLIS Peripheral Infusion System

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por COVIDIEN IIC || EV3 INC.

¿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
  • ID del evento
    R1502-74
  • Número del evento
    2014DM-0012263
  • Fecha
    2015-02-18
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that a manufacturing error caused balloon inflation ports to be mislabeled, which may cause the physician using the device to inflate balloons in the wrong order, causing potential formation of blood clots that may be dislodged and mobilized within of the lungs, leading to the generation of possible adverse events on the patient.

Device

TRELLIS Peripheral Infusion System
  • Modelo / Serial
    TRELLIS 6 and TRELLIS 8, models BVT608010, BVT608030, BVT612010, BVT612030, CVT808015, CVT808025, || CVT812015, CVT812025, EVT808015, EVT808025, || EVT812015V01 and EVT812025V01, specific lots
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    The TRELLIS peripheral infusion system is designed for the controlled and selective infusion of liquids, includingtrolyolitics, inside the peripheral vasculature.
  • Manufacturer
    COVIDIEN IIC || EV3 INC

Manufacturer

COVIDIEN IIC || EV3 INC
  • 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
    NIDFSINVIMA