Alerta De Seguridad para INFUSION PUMP LIFECARE PLUM A + (Registro Anvisa: 80253310023).

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..

¿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
    1051
  • Fecha
    2011-03-11
  • 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 record holder, the problem is related to improper mounting of the buzzer on one of the electronic boards of the pumps. The problem was identified through reports of alarm failure reported by users of the pumps, sent globally to the company. Hospira identified an incidence less than 1 (one) reported failure per million infusions, based on these reports.
  • Causa
    Possibility of failure of the sound alarm of the equipment.
  • Acción
    The registry holder has informed that it will communicate to clients a sound alarm test methodology, to verify the problem. The solution to the problem is still being developed by the company. If you have this infusion pump in your inventory and you have verified problems with this product, or if you want to clarify your doubts with Hospira Produtos Hospitalares Ltda., Use the phone number 0800-7733-133.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA