Events

Alerta De Seguridad para COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7

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

¿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
    2015-05-08
  • Fecha de publicación del evento
    2015-05-08
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150508.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 healthcare colleague single channel cxe pump, v1 .7 medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning colleague single channel cxe pump, v1.7 with item code 2m91617 and serial number 21010369dl. according to the safety alert, the issue is related to the use of an incorrect user interface module (uim) during service. the use of the incorrect spare part could lead to a pump shutdown without an alarm (silent shutdown) if the uim printed circuit board assembly fails. this defect could occur before starting or during therapy that could potentially cause a delay of infusion or interruption of infusion. according to the local supplier, the affected products are distributed in hong kong. the manufacturer will collect the affected device for correction. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 may 2015.

Device

COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter Healthcare COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare