Events

Alerta De Seguridad para Kimvent Subglottic Suctioning Endotracheal Tubes

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

¿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
    2014-11-21
  • Fecha de publicación del evento
    2014-11-24
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141124.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: halyard health (kimberly-clark) kimvent* subglottic suctioning endotracheal tubes medical device manufacturer, halyard health, inc. (formerly known as kimberly-clark health care) has issued a field safety notice concerning its kimvent* microcuff* subglottic suctioning endotracheal tube, 8.0mm. the affected product code is 13222. the affected lot numbers, shipped from 20 december 2013 to 30 october 2014, are aa3213, aa3213v03, aa3227, aa3227v01, aa3239, aa3239v01, aa3245, aa3245v02, aa3249, aa3249v01, aa3249v03, aa3253v02, aa3269v01, aa3274, aa3274v01, aa3274v04, aa4038, aa4038v03, aa4038v04, aa4038v06, aa4062, aa4062v01, aa4062v03, aa4062v04, aa4083, aa4083v02, aa4097, aa4097v02, aa4097v04, aa4104v01, aa4104v02, aa4111, aa4111v01, aa4111v02, aa4113v01, aa4125v03, aa4134v01, aa4146v01, aa4146v04, aa4155v03, aa4167v01, aa4170v01, aa4174v01, aa4217v01 and aa4226v01. according to the manufacturer, the standard kimvent* microcuff* endotracheal tubes are not impacted. the manufacturer has identified that the inflation line of certain kimvent* microcuff* subglottic suctioning endotracheal tubes may detach from the endotracheal tube during use. in most reported cases, detachment of the inflation line was identified immediately, while in other cases, eventual decrease in ventilator circuit pressure triggered ventilator alarms. in the majority of occurrences, re-intubation of the patient was required to re-establish the desired pressure in the ventilator circuit. one suspected case of ventilator associated pneumonia was reported after inflation line detachment, which resolved with standard antibiotic treatment. the manufacturer has initiated a voluntary product recall on the affected lots of devices. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 24 november 2014.

Device

Kimvent Subglottic Suctioning Endotracheal Tubes
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Descripción del producto
    Medical Device Safety Alert: Halyard Health (Kimberly-Clark) Kimvent* Subglottic Suctioning Endotracheal Tubes
  • Manufacturer
    Halyard Health

Manufacturer

Halyard Health