Events

Retiro De Equipo (Recall) de Alaris Pump model 8100

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 CareFusion 303, 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
    68066
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1567-2014
  • Fecha de inicio del evento
    2014-04-23
  • Fecha de publicación del evento
    2014-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126894
  • 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.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    Carefusion is recalling the alaris pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "delay until" option or "multidose" feature is used.
  • Acción
    CareFusion sent an Urgent Medical Device Recall Notification letter dated April 23, 2014, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were informed that if the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician this could result in serious injury or death. Customers are informed although no adverse events or deaths have been reported there is a potential for this risk. If customers experience the issue while using the Alaris Pump module then they are instructed to contact CareFusion Customer Advocacy at (888) 812-3266. Customers are instructed to promptly complete and return the enclosed Customer Response Card to expedite the corrective action process. For questions regarding this recall call 858-617-4000.

Device

Alaris Pump model 8100
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW.
  • Descripción del producto
    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature || The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Dirección del fabricante
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA