Events

Retiro De Equipo (Recall) de Device Recall Alaris

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 Corporation.

¿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
    74142
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2064-2016
  • Fecha de inicio del evento
    2016-05-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146476
  • 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
    A patient weight can be populated incorrectly under certain conditions when using the restore feature to restore infusions running on the alaris lvp module model 8100 and the alaris syringe module model 8110.
  • Acción
    An Urgent Medical Device Recall Letter was sent to customers on 5/31/16 to inform them that BD had identified an issue with the Alaris System PC unit model 8015 with software versions 9.17 and 9.19. Firm has received reports that a patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. The letter informs the customers of the potential risk and the required action for users. Customers are informed that BD will contact them within 60 days to initiate the scheduling process for the software upgrade installation.

Device

Device Recall Alaris
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and worldwide to: Canada, Netherlands, New Zealand and Singapore
  • Descripción del producto
    CareFusion Alaris PC Unit Model 8015 (formerly Medley || PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December || 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
  • Manufacturer
    CareFusion Corporation

Manufacturer

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