Alerta De Seguridad para Easypump C-bloc RA OnDemand

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

¿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
    2013-05-21
  • Fecha de publicación del evento
    2013-05-21
  • 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: b. braun easypump c-bloc ra ondemand the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning easypump c-bloc ra ondemand, manufactured by b. braun medical limited. the affected article number is 4440008 and the affected batch numbers are 152803,182313 and 192472. the manufacturer recently determined that in a small quantity of easypump c-bloc ra pump with ondemand bolus button, the button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position. in this condition, the patient may receive continuous infusion at a rate greater than expected. the manufacturer’s complaint analysis determined that approximately 0.04% of the pumps (i.E.: approximately 4 out of 10,000) may develop this condition. if this condition occurs, it may not be detected during filling or priming of the pump. the use of a pump with this condition may result in over medication of the patient and may potentially result in serious patient injury. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con273701 according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 21 may 2013.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: B. Braun Easypump C-bloc RA OnDemand
  • Manufacturer

Manufacturer