Alerta De Seguridad para Alaris PC Unit, Model 8015

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por CareFusion 303.

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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: carefusion alaris pc unit, model 8015 the united states food and drug administration (fda) issued a class i recall concerning alaris pc unit, model 8015 (part of the alaris electronic infusion pump), manufactured by carefusion 303, inc. the affected unit had power supply board p/n tc 10005122 which were manufactured after january 2011 and were distributed from 1 january 2011 to 31 may 2012. according to fda, a component on the pc unit power supply board is causing an error code (120.4630): "system error" or "missing battery error" to occur. the error code is accompanied by both an audible alarm and a visual error message on the pc unit screen. if the error code occurs at start-up, the alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. if the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient. for details, please refer to fda website http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm314090.Htm and http://www.Fda.Gov/medicaldevices/safety/ listofrecalls/ucm314019.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 2 august 2012.