Events

Retiro De Equipo (Recall) de STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAYER MEDICAL CARE 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
    69529
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-06-12
  • 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 customer complaint was received indicating that the contrast phase of a p3t (personalize patient protocol technology) generated diagnostic protocol was skipped. during an analysis of the issue it was found that the protocol generated via p3t was not achievable by the stellant with certegra work station injector. the system informed the user via pop-up message "insufficient volume for programmed rate". the protocol on the injector head would then revert to the previous injection protocol but the display would continue to reflect the unachievable protocol to the technician. this could lead to a patient being injected with a different protocol than the technician intended. this situation only arises in stellant systems with certegra work stations with sofware version 100.60 or newer that have p3t software enabled.

Device

STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT INJECTION SYSTEM
  • Modelo / Serial
    Model Catalog: 3032458 (Lot serial: 11036); Model Catalog: 3032458 (Lot serial: 11047); Model Catalog: 3032458 (Lot serial: 10493); Model Catalog: 3032458 (Lot serial: 10962); Model Catalog: 3032458 (Lot serial: 11295)
  • Descripción del producto
    STELLANT WITH CERTEGRA WORKSTATION - STELLANT CT
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Dirección del fabricante
    INDIANOLA
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    HC