Events

Retiro De Equipo (Recall) de Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿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
    RC-2016-RN-00339-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-03-23
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00339-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Aisys cs2 anaesthesia devices and upgraded aisys anaesthesia devices deliver a momentary, self-correcting increase of the anaesthetic agent, affecting the inhaled and exhaled concentrations for a short time, upon either of the following setting changes:· a fresh gas setting change from 95%-25% oxygen to only air (21% oxygen).· any total flow setting change while using 21% oxygen (air only). the momentary bolus of anaesthetic agent will not occur with nitrous oxide as the carrier (balance) gas or if the oxygen concentration is set above 21% (air only). delivery of this momentary bolus of anaesthetic agent is potentially hazardous because it could lead to hypotension in certain vulnerable paediatric patients when 21% oxygen (air only) is used.
  • Acción
    GE Healthcare is advising if possible, an alternative device should be used for paediatric patients until this safety issue is resolved. If 21% O2 in fresh gas is used, any adjustment to the fresh gas flow will deliver a bolus of inhaled anaesthetic agent, however the effects are short in duration. If the issue occurs, the device will automatically recover and return to steady state. Depending on your system configuration, one or both of these alarms could trigger if this issue occurs: -Clinician adjustable “Fi XXX High” alarm (XXX denotes the specific agent) -Alarm if respiratory gas monitoring is not present. GE will be providing a correction as a permanent fix. This action has been closed-out on 20/02/2017.

Device

Aisys CS2 and upgraded Aisys anaesthesia devices (with software version 10.X)

Manufacturer

GE Healthcare Australia Pty Ltd