Alerta De Seguridad para Plum A+ infusion pumps and Plum A+3 infusion pumps

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

¿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
    2015-03-06
  • Fecha de publicación del evento
    2015-03-06
  • País del evento
  • Fuente del evento
    DH
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: hospira plum a+ infusion pumps and plum a+3 infusion pumps the united states food and drug administration (fda) posted a medical device safety alert concerning plum a+ infusion pumps and plum a+3 infusion pumps [list numbers: 11005 and 20678. serial numbers: refer to the link below] manufactured by hospira inc. the manufacturer is initiating a recall as the system alarms which should sound when a therapy is interrupted may fail to sound. it is possible for a long delay before a health care professional becomes aware of the need to restore therapy. for patients receiving critical intravenous medication, there is a risk of injury resulting from this potential prolonged interruption in therapy. for details, please refer to the following link: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm436770.Htm according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 march 2015.

Device

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH