Events

Retiro De Equipo (Recall) de ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    46187
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-07-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    A potential risk has been identified that is associated with the power supply board used with the alaris pc unit model 8015 manufactured after january 2011. a component (u21) on this power supply board is causing an error code (120.4630) "system error" or "missing battery error" at start up. when the 120.4630 "system error" code or "missing battery error" error code is observed this could cause a potential delay of therapy at start up or if observed while infusing the inability to make programming changes to current infusions which may result in serious injury and /or death. during infusion the buttons on the channel operate as expected. this error code has not been confirmed to occur during infusion.

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Modelo / Serial
    Model Catalog: 8015 (Lot serial: Contact manufacturer.); Model Catalog: 8015 (Lot serial: >10 serial numbers.)
  • Descripción del producto
    Alaris PC Unit model 8015
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.