Events

Retiro De Equipo (Recall) de ARTIS DIALYSIS SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARDINAL HEALTH CANADA 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
    39421
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-01-26
  • 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
    Gambro is reminding users of the importance of following the instructions in the operating manual when alarm 642 "arterial chamber level adjustment required" occurs which indicates low blood level in the arterial chamber. gambro has become aware of events where the instructions have not been followed and this may deactivate the alarm mechanism. the manual provides instructions on how to increase the blood level and advises that if the reset buton is pressed without adjusting the blood level the alarm will no longer be triggered during the remaining treatment time. performing the treatment with blood level too low in the arterial chamber may result in microbubbles smaller than 20 micro litres reaching the patient.

Device

ARTIS DIALYSIS SYSTEM
  • Modelo / Serial
    Model Catalog: 112949 (Lot serial: ALL SERIAL NUMBERS)
  • Descripción del producto
    Artis Dialysis System equipped with SW 8.09.12 & 8.09.13
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC