Events

Retiro De Equipo (Recall) de CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LivaNova 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-2017-RN-01408-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-11-13
  • 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-01408-1
  • 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
    During internal testing, livanova identified that there is a possibility that the automatic line closure by the erc clamp after detection of an air bubble could take longer than is intended by design in the cp5 system. this could lead to the remote possibility of an air bubble reaching a patient before the clamp closes if the blood flow rate is high and the distance between the bubble sensor and the patient is set at the minimum required by the ifu (1 metre). to date, livanova has not received any reports that an air bubble has passed the erc clamp, nor have there been any reports of patient injury associated with this issue.
  • Acción
    LivaNova is advising users to ensure an arterial filter is used to reduce the probability of air ingress to the patient's bloodstream. LivaNova will be installing a firmware upgrade as a permanent correction.

Device

CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
  • Modelo / Serial
    CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017ARTG Number: 94208 (LivaNova Australia Pty LtdCirculatory assist unit, pump, centrifugal)
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd