Events

Retiro De Equipo (Recall) de Device Recall Alaris PC unit, Model 8015

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
    73631
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1606-2016
  • Fecha de inicio del evento
    2016-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144638
  • 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
    The alaris pc units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (c245) at power up on the alaris pc unit logic boards.
  • Acción
    The firm, Carefusion, sent a "Medical Device Recall Notification" letter dated March 30, 2016 to its customers. The letter described the product, problem, the potential risk involved and the required action for users. The customers were instructed to do the following: If you observe System Error code 133.6080, remove the PC unit from use and contact the CareFusion Support Center, and promptly complete and return the enclosed Customer Response Card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018 from 7am-4pm PST, M-F, or by email at supportcenter@carefusion.com. Customers with clinical inquiries, product complaints, or clinical troubleshooting are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7 days/week or by email at customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PST, M-F or by email at dl-us-inf-techsupport@carefusion.com.

Device

Device Recall Alaris PC unit, Model 8015
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Australia, Great Britain and Canada.
  • Descripción del producto
    Alaris PC unit, Model 8015 || The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
  • 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