Events

Alerta De Seguridad para Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02

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

¿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
    2015-01-14
  • Fecha de publicación del evento
    2015-01-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150114.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: gambro artis/evosys dialysis system equipped with sw 8.15.06 and 8.33.02 medical device manufacturer, gambro, has issued a field safety notice concerning artis/evosys dialysis system equipped with sw 8.15.06 and 8.33.02. the manufacturer reminds users of the possibility that foam may be formed in the venous blood circuit when the extracorporeal circuit is primed using on-line priming. the priming volume specified in the operator’s manual and in the dialyzer instruction for use may not be sufficient to completely eliminate any air trapped in the dialyzer fibres. when this occurs, some foam may be created in the venous circuit during patient connection and during the first few minutes of treatment. the condition is visible to the operator. the potential hazard would be presence of some foam in the venous patient line. the air bubble detection system is designed to stop the blood pump when macro bubbles greater than 20 μl are detected. the presence of operator also reduces the risk of foam reaching the patient. according to the local supplier, only the artis dialysis system is distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 january 2015.

Device

Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Gambro Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02
  • Manufacturer
    Gambro

Manufacturer

Gambro