Events

Retiro De Equipo (Recall) de Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific 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-01500-1
  • 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-01500-1
  • 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
    Radiometer has recently become aware of a potential issue with the pico 70 arterial blood sampler, 956-522 of lot rw-55. it has been reported overseas that some needles seem to be corroded. the use of an arterial blood sampler contaminated with rust particles could lead to blood stream infection and organ damage. to date, no incidences have been reported in australia.
  • Acción
    Radiometer is requesting customers to quarantine stock from lot 956-522RW55. Radiometer will arrange for the collection of the affected product and replacement of this stock. Patients that have been exposed to the affected lot of Pico 70 Arterial blood sampler should be closely monitored for signs of infection or other adverse events. This action has been closed-out on 28/02/2018.

Device

Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers)
  • Modelo / Serial
    Pico 70 Arterial blood sampler (used with Radiometer Blood Gas Analysers) Lot Number: 956-522RW55ARTG Number: 135319
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd