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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-200
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
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 was received for evaluation which confirmed the damage was localized to the external area around the power inlet with no internal damage. Use of a third party power cord by the facility to connect the device was confirmed. The unit construction complies with iec-60601-1 standards to prevent the likelihood of sustained fire. The comfortmate fluid warmer user guide provides instruction for use of the device and states " do not connect portable multiple-socket outlets or extension cords to the nxstage system one cycler, comfortmate fluid warmer, or pureflow" sl. Use only the power cords supplied by nxstage. ".
 
Event Description
A report was received on 08 dec 2020 from a critical care nurse stating flame was noted after fluid leaked onto the electrical connection of the device during a hemodialysis treatment on (b)(6) 2020. Per the nurse, the flame only flashed and the device was removed from use with no patient harm or 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 Key11065890
MDR Text Key224251930
Report Number3003464075-2020-00084
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K012832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFW-200
Device Catalogue NumberCOMFORTMATE FLUID WARMER ASSEM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
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: 12/23/2020 Patient Sequence Number: 1
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