Alerta De Seguridad para LifeCare Plum A +, Registration # 80253310023 - Serial Numbers - Attachment

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Hospira Produtos Hospitalares Ltda.; 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
  • ID del evento
    1614
  • Fecha
    2015-06-09
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
    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
    According to the manifestation of the company, no complaints of health problems were identified due to the problem described above. The Spanish language is immediately displayed when the infusion pump is switched on, reading the screen or labeling. If the infusion pump is put into use and the problem is not identified prior to clinical use, attempts by health professionals to program the infusion pump without understanding instructions and other texts on the screen may lead to a programming error incorrect) or a delay in therapy.
  • Causa
    Hospira has identified some plum a + infusion pumps with labeling and software in the spanish language.
  • Acción
    The company that registers in Brazil recommends that the institution notify the professionals about the notification. To correct the problem, Hospira will replace pumps with information in Portuguese.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA