Events

Retiro De Equipo (Recall) de Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount; Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ICU Medical Australia 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-2014-RN-00877-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-08
  • 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-2014-RN-00877-1
  • 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
    Icu medical has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. a leaking luer may have the potential effect of blood leakage or air embolism which may be life threatening or cause permanent severe injury or illness to the patient. there have been no reports of patient injury due to this problem.
  • Acción
    ICU Medical Australia Pty Ltd is requesting their customers to inspect their stocks and quarantine all units from the affected lots. This action has been closed-out on 03/06/2016.

Device

Transpac Monitoring Kits Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcr...
  • Modelo / Serial
    Transpac Monitoring KitsArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount Item Number: 011-46104-42Lot Numbers: 2841944, 2841945, 2859326, 2865873 & 2869445Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP Item Number: 011-46106-72Lot Numbers: 2841690, 2841691 & 2859331ARTG Number: 206780
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA