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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 NX1000-3-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Renal Failure (2041)
Event Date 10/13/2021
Event Type  Injury  
Manufacturer Narrative
The involved device was not received for evaluation. A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. Factors outside the scope of nxstage therapy can impact the patient''s electrolytes, these include but are not limited to dietary and supplemental intake and the patient's comorbidities. The user guide (ug) warns "appropriate monitoring of the patient¿s hemodynamic, fluid, electrolyte, and acid-base balance should be performed regularly, per physician orders, to ensure appropriate response to therapy". (b)(4).
 
Event Description
A report was received on 16 oct 2021 from the home therapy nurse (htn) of a (b)(6)-year-old male patient with a medical history including multiple comorbidities and end stage renal disease, who stated that the patient experienced headache and hypertension (systolic in 220s mmhg) and required hospitalization following hemodialysis treatment on (b)(6) 2021. Additional information was received on 22 oct 2021 from the htn stating that the patient was admitted to hospital (b)(6) 2021 with a diagnosis of uncontrolled hypertension, headache, acute on chronic renal failure and hyperkalemia (7. 1 mmol/l). Hospitalization included pharmacologic intervention (sodium bicarbonate, calcium gluconate, insulin and glucose) and dialysis therapy with stabilization of the patient¿s laboratory values and vital signs. Over the counter supplements containing potassium were discontinued and the patient recovered without sequelae. The patient was discharged on (b)(6) 2021 to continue hemodialysis therapy using the nxstage system.
 
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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
MDR Report Key12736837
MDR Text Key279775556
Report Number3003464075-2021-00062
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3-A
Device Catalogue NumberCHRONIC HI-FLOW CYCLER, ROHS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/02/2021 Patient Sequence Number: 1
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