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[/t][/t][/c][/t][/t][/t][/t][/t][/t][/t][/t][/t][/font](http://image.digital.nxstage.com/lib/fe8a13737563017572/m/1/c99b0b01-0801-41c3-af07-4fe668eb085b.png)[/t][/t][/t]Medical Device Product Safety Notice
NxStage Express Fluid Warmer
FW-300, FW-300-WW, FW-300-A, FW-301, FW-301-A
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June 11, 2018[/font]
Dear NxStage User:
Description of Problem
We are issuing this Product Safety Notice to notify you about a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. This risk exists any time the warmer is plugged in.
Potential Risk
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.
We are updating our Express Fluid Warmer User Guide to add the following new warning language: [/font]Warning: Do not use any fluid bags that are leaking, and use caution not to spill fluids near the warmer. If the warmer is plugged in, leaking or spilled fluids in the warmer power receptacle can cause an electrical short even if the warmer is not being used. This can lead to an electrical fire and risk of serious injury or death. To minimize this risk, do the following:- When not used during treatment, do not plug the Express Fluid Warmer into the cycler.
- Check all fluid bags for leaks prior to and during use.
- If fluid spills onto the warmer, unplug the warmer power cord from the rear power receptacle and contact Technical Support.
[/t][/t][/t]What do you need to do? [/font]- Please follow the instructions on the attached reply form to confirm that you received this notice.
Please observe the above warning and unplug your Express Fluid Warmer when not in use.
- Please know that we are committed to continuous improvement to provide you with the best products available. We apologize for any inconvenience that this issue may have caused. If you have any questions or comments, please feel free to contact NxStage UK Customer Care at 0800 048 8352 (http://ihatedialysis.com/forum/tel:0800%20048%208352).
Regards,[/l](http://image.digital.nxstage.com/lib/fe8a13737563017572/m/1/55e9561e-8797-41a9-8d52-4609934e117b.png)[/t][/t][/t] Todd M. Snell
Senior Vice President, Quality Assurance, Regulatory, Clinical Affairs
[/t]| Click Here to Digitally Submit the Form (http://click.digital.nxstage.com/?qs=7fbbf2ac4d56ff200d609e9b0e96b67af24a07f9a5eecee45556cd3164bd9086d5abcf7b33906b81013cbb7d0a6dd108)[/font][/t][/t][/t][/t][/t] |
[/t][/t][/t]| Click Here to Print and Mail the Form (http://click.digital.nxstage.com/?qs=7fbbf2ac4d56ff20e0b2630aba5a6bf5b59ce31d31e66c8b3896657d27bb2d53ad55f67c71256d7fbfbb2b11ead859ff)[/font][/t][/t][/t][/t][/t] | [/t]| NxStage Medical, Inc. is a leading medical technology company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of end-stage renal disease (ESRD) and acute kidney failure. NxStage also has established a small number of dialysis clinics committed to the development of innovative care delivery models for patients with ESRD. Read more... (http://click.digital.nxstage.com/?qs=7fbbf2ac4d56ff201433a1d1d76cf48eb467fcf7caffddd4c92b9d8d9e16968dc1493e2be8510dab137e3969d116978b) NxStage Medical, Inc.
350 Merrimack Street (http://ihatedialysis.com/forum/x-apple-data-detectors://3/1)
Lawrence, MA 01843 (http://ihatedialysis.com/forum/x-apple-data-detectors://3/1)
1-866-NXSTAGE (http://ihatedialysis.com/forum/tel:1-866-NXSTAGE) (697-8243 (http://ihatedialysis.com/forum/tel:697-8243)) [/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t][/t] |
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