Events

Recall of Arcomed Volumed Set for Pump Type Volumed µVP 5005/7000 PVC and Gravity Use

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Admedus Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00367-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00367-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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
  • Model / 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