Events

Alerta De Seguridad para CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL

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
    2015-05-12
  • Fecha de publicación del evento
    2015-05-12
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150512.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 ce infusor patient control module watch (pcm), 0.5 ml medicines and healthcare products regulatory agency (mhra), united kingdom, posted a medical device safety alert concerning ce infusor patient control module watch (pcm), 0.5 ml [product code: 2c1079k. lot number: 13m061. expiry date: 30 nov 2016] manufactured by baxter healthcare. the manufacturer received complaints that reported leak in the reservoir. this issue is being investigated and only affects the 0.5 ml pcm watch. the leak in the reservoir may lead to medication contamination, which could result in infection or other serious adverse health consequences. product recall is on-going. according to the local supplier, the affected lot is not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 may 2015.

Device

CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare