Events

Retiro De Equipo (Recall) de Device Recall Plum A Infusion Pump, Single Channel

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Hospira Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    64261
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2726-2016
  • Fecha de inicio del evento
    2013-02-06
  • Fecha de publicación del evento
    2016-09-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115714
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    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
    Pump, infusion - Product Code FRN
  • Causa
    The fluid shield diaphragm for the plum a+ infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
  • Acción
    Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field.

Device

Device Recall Plum A Infusion Pump, Single Channel
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.
  • Descripción del producto
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA