Events

Retiro De Equipo (Recall) de ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

¿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-2018-RN-00220-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-03-13
  • 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-2018-RN-00220-1
  • 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
    Emergo has been notified by the manufacturer, transonic systems (transonic), that the sterility of adt1018 flow qc tubing set cannot be assured. transonic is not aware of any actual products that are not sterilized; however, there is a small risk that unsterilized product may have been released. given this possibility, in the event the adt1018 flow qc tubing were to be used without being sterilized, this would increase the risk of infection post use for patients who have come into contact with any unsterilized product. to date, no complaints or adverse events have been reported to transonic related to this issue.
  • Acción
    Transonic has discontinued the ADT1018 product line and has ceased purchasing product from this supplier entirely. The ADT1010 tubing set replaces ADT1018 Flow QC tubing. Emergo is advising users to immediately discontinue use and distribution of the affected product. Return or destroy the affected product and document that destruction on the Medical Device Recall Return Response Form provided with the Customer Letter. Upon receipt of the completed form a product replacement will be issued. If it appears that any patients have had contact with the ADT1018 Flow QC tubing set, please observe these patients for any signs of infection as per your hospital protocol and report if any such events take place.

Device

ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set
  • Modelo / Serial
    ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set Catalogue Number: ADT1018Lot Numbers: B151130E2 and B161115E0Expiry: 30/11/2018 and 15/11/2019Catalogue Number: ADT1018-40Lot Numbers: B151130E2 and B161115E0Expiry: 30/11/2018 and 15/11/2019ARTG Number 187558
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia