Events

Retiro De Equipo (Recall) de Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Admedus 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-2018-RN-00367-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-18
  • 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-2018-RN-00367-1
  • 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
    Admedus has been made aware that some users have been experiencing problems when priming the infusion lines prior to connecting them to the patient. in clinical practise, nurses will generally “prime" the lines some time before connecting to the patient. during the time between priming and connection to the patient, observations of bubbles and lost fluid have been made, even when the clamp and roller are closed. admedus have identified that this issue is isolated to the lines containing a 0.2 micron filter when priming of the line has been performed with an inverted filter.
  • Acción
    Admedus are advising they are providing customers with a revised Instructions for Use (IFU) which includes information on correct priming and storage of the lines. A side clamp will be added to the distal end of the set - between the Y-site and the Luer to prevent leakage even if the operator does not follow the priming and storage instructions outlined in the IFU. Until the re-designed lines are available (expected March-May 2019), side clamps will be provided for clinicians to add on the line prior to priming.

Device

Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use
  • Modelo / Serial
    Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use Product Code: ALPPK1SVJ1FARTG Number: 274187(Admedus Australia - Electric infusion pump administration set)
  • Manufacturer
    Admedus Australia Pty Ltd

Manufacturer

Admedus Australia Pty Ltd