Events

Retiro De Equipo (Recall) de Colied-Tube INFUSOR System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare 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-00448-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-17
  • 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-00448-1
  • 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
    Baxter is issuing a safety alert to notify users of factors that can contribute to over-infusion. when multiple factors are combined infusion rates can be in excess of 30% greater than the nominal flow rate. additionally, end users are being notified of a correction to the instructions for use. recent review of flow rate testing by baxter has identified that the nominal flow rate is achieved when the elastomeric reservoir is positioned 15-20cm below the distal luer lock.
  • Acción
    Baxter is reiterating the factors that may impact flow rate as described in the instructions for use (IFU). Baxter is also notifying end users of an amendment to the instructions for with regard to the optimal Elastomeric Reservoir position. End users are advised that nominal flow is achieved when the Elastomeric Reservoir is positioned 15-20cm below the distal luer lock and not when positioned at the same height as stated in the IFU.

Device

Colied-Tube INFUSOR System
  • Modelo / Serial
    Colied-Tube INFUSOR SystemProduct Codes:2C1071KJP - Single Day Infusor 2 ml/h System2C1071KJ - Single Day Infusor 2 ml/h System2C1073KJP - Half Day Infusor SV 5 ml/h System2C1075KJP - Two Day Infusor 2 ml/h System2C1080KJP - Multi Day Infusor 0.5 ml/h System2C1082KJP - Seven Day Infusor 0.5 ml/h System2C1082KJ - Seven Day Infusor 0.5 ml/h SystemARTG Number: 46196
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd