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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 Edema (1820); High Blood Pressure/ Hypertension (1908)
Event Date 08/05/2020
Event Type  Injury  
Manufacturer Narrative
A review of the device history record confirmed the product was released meeting all quality criteria and manufacturing specifications. Factors outside the scope of nxstage therapy can impact the patient''s weight, these include but are not limited to the accuracy with which intake is recorded, the weighing techniques used, and the patient''s comorbidities. Udi: (b)(4).
 
Event Description
A report was received on (b)(6) 2020 from the home therapy nurse (htn) of a (b)(6) year old female with end stage renal disease, who stated insufficient programmed fluid was removed during hemodialysis therapy on multiple unspecified dates and the patient was hospitalized with fluid overload on (b)(6) 2020. Additional information was received from the htn on 06-12 aug 2020 stating the patient was symptomatic with high blood pressure (nos) and edema. Per the htn, the patient recovered without sequelae, was discharged from hospital (date not provided), and has resumed treatment with the nxstage system. Although requested, no treatment details or hospital records were provided.
 
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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 Key10442215
MDR Text Key204207340
Report Number3003464075-2020-00057
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 01/01/2005,08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
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
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 Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/24/2020 Patient Sequence Number: 1
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