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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 NX1000-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Exsanguination (1841)
Event Date 07/26/2017
Event Type  Death  
Manufacturer Narrative
The device has not been received for evaluation. No log files were received for analysis. The device history record for the cycler was reviewed and the cycler was released having met all requirements in the manufacturing process prior to release with no related defects. Per the center nurse, a test run was performed in center and no issues were noted. The center nurse stated there was no evidence of a device malfunction.
 
Event Description
A report was received on (b)(4) 2017 of a (b)(6) female patient with a 25 year history of chronic kidney failure who was found unresponsive when performing a standard home hemodialysis treatment on (b)(6) 2017. A large quantity of blood was present in the room and the patient subsequently expired at the scene. The source of the blood loss was not identified. No additional information is available. Per the home therapy nurse stated the cause of death was exsanguination.
 
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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
9786874700
MDR Report Key6810078
MDR Text Key83227414
Report Number3003464075-2017-00039
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/22/2017 Patient Sequence Number: 1
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