Events

Retiro De Equipo (Recall) de NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Aero Healthcare.

¿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-01138-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-16
  • 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-01138-1
  • 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
    During the operation of the nio-a, the needle was not released from the device as expected. the device was placed on the floor and after several minutes the needle was released spontaneously.As the device is intended to penetrate the bone into the marrow cavity, it is designed in such way that the needle is released intensely due to a compressed spring force. spontaneous release of the needle from the device may result in serious injury of the patient, caregiver or any of the surrounding people.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Acción
    Aero healthcare is advising users to return the affected units. This action has been closed-out on 26/05/2017.

Device

NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravasc...
  • Modelo / Serial
    NIO-A device (Automatic intraosseous infusion device that provides rapid, safe and easy intravascular access through the bone marrow)Lot Number: 160024ARTG Number: 145376
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare