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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 Dyspnea (1816); Swelling (2091); Ascites (2596)
Event Date 09/19/2018
Event Type  Injury  
Manufacturer Narrative
No product was received for evaluation. A review of the device history record (dhr) was conducted and confirmed the product was released meeting all quality criteria and manufacturing specifications. (b)(4).
 
Event Description
A report was received on (b)(6) 2018 from the home therapy nurse (htn) regarding a (b)(6)-year-old female patient with multiple complex comorbidities significant for a recent pulmonary infection (nos), morbid obesity, previous myocardial infarction, cardiac arrhythmias, hypertensive heart disease, and previous kidney transplant rejection, who was hospitalized from 19 sep 2018 to 21 sep 2018 with symptoms of shortness of breath, abdominal swelling and leg swelling. The patient received dialysis treatments in hospital for fluid removal and was discharged with a diagnosis of fluid overload unspecified. Per the physician, a relationship to nxstage products and therapy could not be excluded.
 
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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 Key7971403
MDR Text Key123939778
Report Number3003464075-2018-00052
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
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 01/01/2005,10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberNX1000-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received09/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 0
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