Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00798-1
Product Name/Description NxStage Express Fluid Warmer

Models: FW-300, FW-300-WW, FW-300-A, FW-301 and FW-301-A

ARTG Number: 289644
(Regional Health Care Group - Conduction blood/fluid warmer)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 20/06/2018
Responsible Entity Regional Health Care Group Pty Ltd
Reason/Issue 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.
Recall Action Product Defect Correction
Recall Action Instructions NxStage, through Regional Health Care Group have taken the decision to
replace the Instructions for Use with an updated IFU.

This action has been closed out on 09/07/2019
Contact Information 0418 274 034 - Neil Spence from NxStage