| 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 |
|
| 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 |