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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 Insufficient Information (3190)
Patient Problems Fever (1858); Weakness (2145)
Event Date 02/22/2018
Event Type  Injury  
Manufacturer Narrative
The device was not retained for investigation. The device history record was reviewed and no quality issues were noted during the manufacturing of the reported lot number which was released having met all requirements and specifications. The user guide directs the user to follow the physician's prescription and to maintain aseptic technique for treatment and lists infection as a risk of hemodialysis. All available information supports that the product was functioning as designed and there was no malfunction. Biocompatibility of the device has been established. (b)(4) nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2018 from a (b)(6) male patient with a history of non-compliance who reported feeling ill approximately 45 minutes after commencing his home hemodialysis treatment on (b)(6) 2018. Per the home therapy nurse (htn) the patient was hospitalized with fever and weakness from (b)(6) 2018. No additional information has been received.
 
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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 Key7338895
MDR Text Key102385341
Report Number3003464075-2018-00012
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 consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 03/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E W/ SERVICE COMPUTER
Device Lot Number71179116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2009
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: 03/14/2018 Patient Sequence Number: 1
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