Events

Alerta De Seguridad para ABACUS Total Parenteral Nutrition Calculation Software

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

¿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
    2013-12-13
  • Fecha de publicación del evento
    2013-12-13
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131213a.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 abacus total parenteral nutrition calculation software medical device manufacturer, baxter, has issued a field safety notice concerning abacus total parenteral nutrition (tpn) calculation software distributed between may 2006 and may 2013 (software versions: 2.0 through 3.0). the possibility exists that a patient could receive another patient’s tpn order due to data corruption. while no patient harm has been reported for this issue, provision of the wrong admixture to patients receiving tpn therapy may cause severe complications, potentially triggering a chain of complications that may lead to a fatal outcome. baxter is requesting users to be consistent with good pharmacy practice, and check the patient order against the final bag label as part of the tpn acceptance procedure to ensure that the patient’s tpn order is correct. furthermore, the tpn order entry software v3.1 upgrades will be arranged. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 december 2013.

Device

ABACUS Total Parenteral Nutrition Calculation Software
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Baxter ABACUS Total Parenteral Nutrition Calculation Software
  • Manufacturer
    Baxter

Manufacturer

Baxter