Events

Alerta De Seguridad para Infusomat Space Pump - US Version Infusion pump

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

¿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
    2012-03-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120310c.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
    Field safety notice: b. braun infusomat space pump - us version infusion pump the food and drug administration (fda), united states, has issued a class i recall on b. braun infusomat space pump - us version infusion pump, model # 8713050u. fda reported that the affected device has a potential for breakage of anti free flow clip catch when the iv set anti free flow clip is incorrectly inserted into the pump and the pump door forced to be closed. if the clip catch is broken and the door opened, free flow protection is still ensured. however, after the set is manually removed from the pump without the closure of the iv set roller clamp, the anti free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow. when the pump and iv set are operated in accordance with the instructions for use, the potential for free flow is fully mitigated. according to the local supplier, the affected device is not distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/enforcementreports/ucm292057.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

Infusomat Space Pump - US Version Infusion pump

Manufacturer

B. Braun