Events

Alerta De Seguridad para Single Needle Bloodlines for AK Machines

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

¿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
    2014-03-18
  • Fecha de publicación del evento
    2014-03-18
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140318.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: gambro single needle bloodlines for ak machines the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning single needle bloodlines for ak machines, manufactured by gambro. the affected product codes (with batch numbers) are 114524 (batch number: from 1317 to 1350), 114561 (batch number: from 1316 to 1401) and 114527 (batch number: from 1316 to 1321) respectively. according to the manufacturer, there is a possible defect on the concerned products, involving a potential bonding of the venous male luer with the drain bag connector and/or of the arterial male luer with the spike connector. when the defect occurs, the cone of the luer may be damaged if the operator forces the disconnection of the bonded luer. performing a treatment with a damaged luer connection could result in an intake of air into the bloodline which could potentially reach the patient and would not pass through the “air in blood” protective system of the dialysis machine. the manufacturer advises users not to use the affected products, but, instead, use product from different lots or similar product as available. the affected product will be collected and replaced by the manufacturer. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con391268 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 march 2014.

Device

Single Needle Bloodlines for AK Machines
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Gambro Single Needle Bloodlines for AK Machines
  • Manufacturer
    Gambro

Manufacturer

Gambro