Alerta De Seguridad para HDF On-line

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

¿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
    2014-02-18
  • Fecha de publicación del evento
    2014-02-18
  • 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: medica hdf on-line the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the haemodiafiltration device, “hdf on-line” [product code: m03831] manufactured by medica s.P.A. the affected products are identified by the following batch numbers: pv13/0352, pv13/0398, pv13/0401, pv13/0440, pv13/0450, pv13/0457 pv13/0458, pv13/0469, pv13/0504, pv13/0508, pv13/0517, pv13/0518, pv13/0519, pv13/0536, pv13/0538. the manufacturer has become aware that some hdf on-line units may have loose connections between the ultra-filter headers and the tubings. this may lead to a fluid loss from the device, occurring during the priming of the line or during patient treatment. some hdf on-line units may have loose connections between the ultra-filter headers and the tubings which may lead to a fluid loss from the device, occurring during the priming of the line or during patient treatment. according to the manufacturer, if fluid loss from a connector occurs during treatment and it is not detected, this event may cause a fluid imbalance in the patient, with the risk of excessive weight loss (hypovolemia). another potential risk (this has never happened to-date and the probability of occurrence is remote) is the impairment of the sterile barrier which is ensured by the proper tightness of the connections, with the consequent need for medical intervention to prevent further complications. the manufacturer advises all affected users to check the connections of the hdf on-line device are tightly screwed before and after use. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con377619 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 february 2014.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medica HDF On-line
  • Manufacturer

Manufacturer