Events

Alerta De Seguridad para Logical Hemodraw Closed Blood Sampling Systems

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

¿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
    2012-12-11
  • Fecha de publicación del evento
    2012-12-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121211c.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: smiths medical logical hemodraw closed blood sampling systems the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning logical hemodraw closed blood sampling systems, manufactured by smiths medical. the manufacturer has become aware of a potential risk of inadvertent introduction of air into the affected device via a porous plug, if the device is used incorrectly. if a user incorrectly orients the zero stopcock when activating the hemodraw reservoir, air can enter the fluid pathway. air in the line, if not properly handled by the clinician, can be introduced into the patient under specific situations, which are highly unlikely according to manufacturer. smiths medical has received no reports of patient injury or death related to this issue. as a precautionary measure, smiths medical is changing its instruction for use to instruct users to fit a non-vented cap to the stopcock after priming. the field safety notice provides these additional instructions to users who have been supplied the affected products. the manufacturer will also supply users with non-vented caps for the affected devices. for details, please refer to the following mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con213146 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

Logical Hemodraw Closed Blood Sampling Systems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Smiths Medical Logical Hemodraw Closed Blood Sampling Systems
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical