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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); Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation which confirmed the damage was localized to the external area around the power inlet with no internal damage. The unit construction complies with iec-60601-1 standards to prevent the likelihood of sustained fire. The material for the unit is flame retardant as per the applicable rating (ul94v-0). The express fluid warmer user guide provides instruction for use of the device and states "use only the power cords supplied by nxstage or its authorized distributors. Do not connect portable multiple-socket outlets or extension cords to any nxstage equipment. Non-authorized or incompatible electrical power cords and outlets can create an electrical hazard. " (b)(4).
 
Event Description
A report was received on (b)(6) 2020 from the care partner of a (b)(6) male with a medical history of end stage renal disease, stating the express fluid warmer caught fire after fluid dripped into the device while preparing for a home hemodialysis treatment on (b)(6) 2020. Additional information was received on 02 dec 2020 from the home therapy nurse (htn) who stated the patient was not connected to the device at the time of the event and there was no patient harm or damage to property. Per the htn there was a short in the home circuit breaker affecting the usual power outlet used by the patient. The device was connected via an extension cord to a power outlet in another room and the patient was preparing the device for initiation of treatment. The htn stated the patient continues to treat using the nxstage system and a replacement device.
 
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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 Key11041645
MDR Text Key222853886
Report Number3003464075-2020-00083
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 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFW-300
Device Catalogue NumberEXPRESS FLUID WARMER
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
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: 12/18/2020 Patient Sequence Number: 1
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