Events

Alerta De Seguridad para infusion pump Plum 360

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Hospira Costa Rica Ltd || 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
    I1711-541
  • Número del evento
    2015EBC-0013856 ; 2016DM-0015057
  • Fecha
    2017-11-22
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=64
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data

Device

infusion pump Plum 360
  • Modelo / Serial
    PLUM 360, with versions of Hospira Mednet Meds 6.1 and 6.2.1
  • Descripción del producto
    HOSPIRA PLUM 360 single infusion pump is indicated for parenteral, enteral and epidural treatments and in the administration of blood components. HOSPIRA MEDNET MEDICATION MANGEMENT SUITE (MMS) is indicated to facilitate network communication between compatible computer systems MMS and infusion pumps HOSPIRA. "HOSPIRA MEDNET" provides trained health professionals with the ability to send, receive, report and store information from externally interconnected systems, and configure and edit the programming of infusion parameters. "HOSPIRA MEDNET" is intended to provide a way to authorize programming of infusion parameters, thus decreasing the number of manual steps necessary to introduce the infusion data.All data entry and validation of infusion parameters is performed by a qualified health professional in accordance with the doctor's orders.
  • Manufacturer
    Hospira Costa Rica Ltd || Hospira Inc

Manufacturer

Hospira Costa Rica Ltd || Hospira Inc
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    NIDFSINVIMA