Events

Alerta De Seguridad para Alaris Pump Module, Model 8100

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
    2012-08-23
  • Fecha de publicación del evento
    2012-08-23
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120823.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: carefusion alaris pump module, model 8100 the united states food and drug administration (fda) has issued a class i recall concerning alaris pump module, model 8100 (formerly medley pump module), manufactured by carefusion 303, inc. the manufacturer had identified that there is a potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly with keypad part number tc10005926. this could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. when infusion stops, serious injury or death may result. customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation. for details, please refer to the following fda websites http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ ucm316612.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm316637.Htm. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 august 2012.

Device

Alaris Pump Module, Model 8100

Manufacturer

CareFusion 303