Events

Retiro De Equipo (Recall) de Spectra Optia Apheresis machine

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Terumo BCT 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-2014-RN-00124-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-05
  • 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-2014-RN-00124-1
  • 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
    Terumo bcthas identified that pinhole leaks may occur due to stresses on the channel weld, particularly during long procedures on spectra optia. if leaks occur during use the procedure must be discontinued.Terumo bct has received reports relating to leaks in the channel of the tubing set of the spectra optia. these leaks have many different causes, including operator misloading. a very specific type of channel leak, a 'pinhole' leak at a specific location reported by customers primarily during long mnc procedures have been identified.
  • Acción
    Terumo BCT is installing a modified filler at the next scheduled preventative maintenance to mitigate the risk of leakage. The device can continue to be used while awaiting the replacement filler. Users should be aware of the potential for leakage and cease any procedure if leakage is observed.

Device

Spectra Optia Apheresis machine

Manufacturer

Terumo BCT Australia Pty Ltd