Events

Retiro De Equipo (Recall) de Device Recall Alaris PC unit

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
    71081
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1811-2015
  • Fecha de inicio del evento
    2015-05-13
  • Fecha de publicación del evento
    2015-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-05-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136048
  • 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
    An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. an infusion may start that is greater than or less than the hospital established limits for the specific medication.
  • Acción
    CareFusion sent an Urgent Medical Device Recall Notification letter dated May 13, 2015 to customers. The letter identified the affected product, problem and the recommended actions to be taken. Customers are informed that CareFusion has released a software upgrade to address this issue. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the software upgrade installation. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PT, supportcenter@carefusion.com. Customers with adverse event report questions are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days a week, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PT, Mon-Fri, dl-us-inf-techsupport@carefusion.com.

Device

Device Recall Alaris PC unit
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Alaris PC unit model 8015, Infusion pump. software version 9.17 || Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
  • 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