Events

Retiro De Equipo (Recall) de Alaris Syringe Module Model 8110

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
    74508
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2879-2016
  • Fecha de inicio del evento
    2016-08-08
  • 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=147801
  • 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 software anomaly with the alaris syringe module software version 9.15 may cause an infusion to unexpectedly stop when the syringe module is transitioning from one rate to another.
  • Acción
    The firm, BD, sent an "Urgent: Medical Device Recall Notification" letter dated 8/8/16 to customers to inform them that BD has identified a software anomaly associated with the Alaris Syringe module software version 9.15. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the instructions and promptly complete and return the Customer Response Card to expedite the corrective action process. Customers with recall related questions are instructed to contact the BD Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229.

Device

Alaris Syringe Module Model 8110
  • Modelo / Serial
    Software version 9.15
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.
  • Descripción del producto
    Alaris Syringe Module Model 8110 with software version 9.15 || The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
  • 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