Events

Alerta De Seguridad para INFUSOR Portable Elastomeric Infusion System

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

¿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
    2014-03-05
  • Fecha de publicación del evento
    2014-03-05
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140305.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: baxter infusor portable elastomeric infusion system medical device manufacturer, baxter healthcare sa has issued a medical device safety alert concerning infusor portable elastomeric infusion system with product codes 2c1071kjp, 2c1075kjp and 2c1976kj. all lot numbers within expiration dating are affected. while there have been no changes made to the product, recent review of flow rate testing has shown that the nominal flow rate as labelled is achieved when the elastomeric reservoir is positioned 6-8 inches (15-20 cm) below the distal luer lock and not when positioned at the same height as stated in the directions for use. if the device is positioned according to the current directions for use, a greater than intended flow rate (up to 4%) may occur. therefore, the manufacturer now advises users to position the infusion system’s elastomeric reservoir 6-8 inches (15-20 cm) below the distal luer lock in order to achieve the labelled flow rate. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 march 2014.

Device

INFUSOR Portable Elastomeric Infusion System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter INFUSOR Portable Elastomeric Infusion System
  • Manufacturer
    Baxter Healthcare SA

Manufacturer

Baxter Healthcare SA