Alerta De Seguridad para Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump

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

¿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
    2014-12-23
  • Fecha de publicación del evento
    2014-12-23
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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 healthcare colleague p1.7 cxe single channel pump and colleague p1.7 cxe triple channel pump medical device manufacturer, baxter healthcare ltd. has issued a safety alert for the following infusion pumps: colleague p1.7 cxe single channel pump (product code 2m91617) and colleague p1.7 cxe triple channel pump (product code 2m91637) according to the safety alert, the manufacturer reminds users to reset the manual tube release (mtr) when it is left in the open position. users that do not follow the labeled instructions for resetting the mtr prior to use will be unable to power on the device. this has the potential to lead to a delay in therapy. 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 23 december 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Healthcare Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump
  • Manufacturer

Manufacturer