Events

Retiro De Equipo (Recall) de Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of autologous blood in postoperative and trauma blood loss management)Systems affected - Ocean, Oasis

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Atrium Australia - Pacific Rim Pty Limited.

¿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-2013-RN-01159-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-15
  • 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-2013-RN-01159-1
  • 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
    Atrium medical has become aware that the force required to detach the tubing from the drain may be lower than atrium medical's product specifications. the manufacturer has received reports for leaking of blood or disconnection of the drain at the connection point of the ats access line and the chest drain. the leaks or disconnection occurred following usage of the drain in excess of 2 days and typically were related to movement of the patient within the institution.
  • Acción
    Atrium Medical is advising their customers to quarantine affected products and use an appropriate substitute device. If an adequate substitute is not available customers are advised to review the substitution list and contact Atrium for assistance in obtaining the substitute device. It is further advised that in the event of an emergency situation the affected devices can continue to be used provided work around instructions are followed.

Device

Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of ...
  • Modelo / Serial
    Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of autologous blood in postoperative and trauma blood loss management)Systems affected - Ocean, OasisProduct Codes: 2050-300, 3650-100Lot/Serial Numbers: 10883118, 10891209, 10899344, 10883101, 10891238, 10906323ARTG Number: 126675
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA