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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 Chest Pain (1776); Fatigue (1849); Blood Loss (2597)
Event Date 11/27/2017
Event Type  Injury  
Manufacturer Narrative
The device has not been received for evaluation. Review of the log file received for 28-nov-2016 supports that there was no device malfunction. The cycler alarmed appropriately to alert the user to the presence of air and low venous pressure. The nxstage user guide warns the user to contact their center when blood loss is experienced. Nxstage medical considers this report closed. No additional information will be provided. This report and the information contained herein is submitted to the food and drug administration under 21 cfr part 803 and represents the information available to the company at the time of the report.
 
Event Description
A report was received on (b)(6) 2017 of a female patient receiving standard home hemodialysis therapy who experienced blood loss totaling 420ml over two consecutive days. The patient elected to discard a cartridge of blood on (b)(6) 2016 and a second cartridge the next day, for unspecified reasons. The patient reported chest pain and fatigue, went to the hospital, received a unit of blood and was released to home.
 
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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 Key6440439
MDR Text Key71092764
Report Number3003464075-2017-00019
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received03/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2014
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: 03/28/2017 Patient Sequence Number: 1
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