Events

Recall of NxStage Express Fluid Warmer

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Regional Health Care Group 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-00798-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00798-1
  • 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
    Nxstage has identified a potential risk of electrical fire, in the event fluid leaks into the power receptacle on the back of the express fluid warmer. this risk exists at any time whilst the warmer is plugged in. nxstage has received 7 reports of smoke, sparks or flames coming from the express fluid warmer since 2016. there have been no adverse health consequences or medical interventions reported as a result of this issue.Given the occurrence of these incidents, the instructions for use (ifu) are being updated with a warning about fluid bags and fluid near the warmer, along with instructions on how to minimise this risk.
  • Action
    NxStage, through Regional Health Care Group have taken the decision to replace the Instructions for Use with an updated IFU.

Device

NxStage Express Fluid Warmer
  • Model / Serial
    NxStage Express Fluid Warmer Models: FW-300, FW-300-WW, FW-300-A, FW-301 and FW-301-AARTG Number: 289644(Regional Health Care Group - Conduction blood/fluid warmer)
  • Manufacturer
    Regional Health Care Group Pty Ltd

Manufacturer

Regional Health Care Group Pty Ltd