Events

Retiro De Equipo (Recall) de Bayer 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-2015-RN-01195-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-07
  • 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-2015-RN-01195-1
  • 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
    Bayer medical care inc. has identified that certain batches of the source administration sets (sas) used with the medrad intego pet infusion system may contain out-of-specification saline tubing and/or solvent occluding the radio pharmaceutical (rp) tubing.The inner diameter of the saline tubing is out-of-specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. the occluded sas tubing may impair the priming function and prompt an “rp prime failed. check sas and vial installation, then reprime.” error message. although unlikely, these situations may lead to procedure delay, false negative result due to incomplete dose, inaccurate dose reporting in the patient record, overdose of rp delivered and in rare situations additional radiation exposure for the operator.
  • Acción
    The sponsor Imaxeon is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. There may be a delay in replacing the affected stock due to limited new inventory. This action has been clsoed-out on 29/08/2016.

Device

Bayer Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System
  • Modelo / Serial
    Bayer Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System [Catalogue Number INT CSS]Multiple batch numbers affectedARTG Number: 154205
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

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