Events

Retiro De Equipo (Recall) de Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Imaxeon 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-01498-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-11-16
  • 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-01498-1
  • 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
    Imaxeon have determined that all current source administration sets (sas) used with the medrad intego pet infusion system may produce particulates in radiopharmaceutical (rp) vials when the needle is inserted. these particulates may be generated when the tip of the needle pushes through the rubber septum of the vial. this presents a potential safety risk of particulate(s) being injected into a patient. to date, there have been no reports of patient or user injury.
  • Acción
    Imaxeon is advising customers to immediately discontinue use of the Intego system and quarantine the SAS disposable units that they have in stock. They are also advised to determine an alternative method of the radiopharmaceutical delivery such as manual injections, if feasible. Imaxeon is in the process of qualifying a compatible in-line filter to be used with the SAS and will advise customers of the results in the next few weeks. Due to the limited inventory, customers may retain their quarantined units to be later used with the in-line filters. Alternatively, customers may return their units back to Imaxeon for a credit.

Device

Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System

Manufacturer

Imaxeon Pty Ltd
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    DHTGA