Events

Alerta De Seguridad para All Plum A+ family of Infusers

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

¿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
    2011-10-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111005.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.
    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
    Field safety notice: hospira all plum a+ family of infusers hospira has issued urgent device recall on plum a+™ family of infusers. the manufacturer has received customer reports involving two safety issues: (1) rebooting of the infusion pumps, and (2) the incorrect seating of the regulatory closer potentially causing unrestricted flow. the first issue is related to the continuous recycling and/or rebooting of plum a+ devices when the "backlight intensity" and/or "display contrast" settings for the lcd display have been adjusted from default setting. this condition can cause a delay in therapy because the clinician would not be able to start the device due to the continuous recycling and/or rebooting. the second issue is related to incorrect seating of the regulator closer that potentially causes unrestricted flow of the infusion pump when the cassette door is opened. the condition may lead to life-threatening adverse events. to correct the issues, hospira will provide software upgrade and technical checkups to affected customers. according to the local supplier, plump a+ infusion pumps have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

All Plum A+ family of Infusers
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Hospira All Plum A+ family of Infusers
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DH