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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number FW-300
Device Problems Fire (1245); Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
All devices must meet quality requirements and manufacturing specifications prior to release, and the device has not been serviced for any similar events. The device meets requirements for electrical and safety standards as outlined in the user guide. The user guide states to inspect the power interconnect cord and the device for damage before each use, and not to use the device if any damage is evident. It warns to plug the warmer into a properly grounded outlet and describes connection for the power cord from a grounded power outlet to the back of the warmer. Per the user guide proper electrical hookup in full compliance with all applicable codes and device specifications must be maintained. Details of the electrical connections at the home or during use are unknown. Udi: (b)(4).
 
Event Description
A report was received on 07 oct 2020 from a (b)(6) year old female who stated sparks and flames were observed on the back of the device during a home hemodialysis treatment on (b)(6) 2020. Additional information was received on 08 oct 2020 from the home therapy nurse (htn) who stated the event occurred approximately one hour into treatment and the patient was unable to complete the hemodialysis session. Per the htn, there was no patient injury and no damage to property.
 
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Brand NameNXSTAGE SYSTEM ONE
Type of DeviceHIGH PERMEABILITY HEMODIALYSIS SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack street
lawrence MA 01843
Manufacturer (Section G)
MEDIMEXICO S. DE R. L. DE C. V
av. valle imperial no. 10523
parque industrial valle sur
tijuana 22180
MX 22180
Manufacturer Contact
paula rogalski
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key10705300
MDR Text Key213684880
Report Number3003464075-2020-00069
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K071263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFW-300
Device Catalogue NumberEXPRESS FLUID WARMER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/20/2020 Patient Sequence Number: 1
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