Events

Alerta De Seguridad para I-Flow On-Q Pump C-Cloc with Ondemand Bolus button

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

¿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
    2012-06-15
  • Fecha de publicación del evento
    2012-06-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120615a.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: i-flow on-q pump c-cloc with ondemand bolus button the health canada posted a medical device safety alert concerning on-q pump c-cloc with ondemand bolus button (model number cb003 and cb006), manufactured by i-flow corporation. the manufacturer recently determined that in a small quantity of on-q pumps including the ondemand bolus button, the valve that activates flow of local anesthetic from bolus reservoir to the patient is defective. in this condition, patients may receive continuous infusion of local anesthetic to the tissue space at a rate greater than desired (i.E. main basal rate + bolus reservoir fill rate). for details, please refer to health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php. if you are in possession of the product, please contact your supplier for necessary actions. posted on 15 june 2012.

Device

I-Flow On-Q Pump C-Cloc with Ondemand Bolus button

Manufacturer

I-Flow Corporation