Events

Retiro De Equipo (Recall) de ClearSight Heart Reference Sensor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Edwards Lifesciences 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-2017-RN-01537-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-22
  • 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-2017-RN-01537-1
  • 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
    Edwards lifesciences has been made aware of reports of “out of range” error messages for the edwards clearsight heart reference sensor. an analysis of evhrs out of range complaints led to the determination that the product is not meeting the current labelled shelf life (expiry date) of 730 days (2 years) from the date of manufacture. as a result, edwards lifesciences are amending the expiration date to six months from the date of manufacture. there have been no reported patient injuries as a result of this issue.
  • Acción
    Edwards Lifesciences are advising customers that they will be in contact with affected users to arrange for replacement of the device. In the interim, if users do not encounter the "HRS Out of Range" message on the EV1000 clinical platform, the HRS is functioning properly and patient monitoring is not adversely impacted.

Device

ClearSight Heart Reference Sensor
  • Modelo / Serial
    ClearSight Heart Reference SensorModel Number: EVHRSAll serial numbers manufactured after December 31, 2015ARTG Number: 219809
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd