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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 CAR-170-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Nausea (1970); Dizziness (2194); Cough (4457); Unspecified Respiratory Problem (4464)
Event Date 08/13/2021
Event Type  Injury  
Manufacturer Narrative
The product was received for evaluation and successfully passed testing, no leaks or occlusions were observed and all luers and connectors were intact with no compromised integrity found. 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. The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly.
 
Event Description
A report was received on 16 aug 2021 from the caregiver (cg) of a (b)(6) male with a medical history including diabetes and end stage renal disease, who stated the patient experienced shivers and a fever (99 f) during a home hemodialysis treatment on (b)(6) 2021. Treatment was terminated and rinse back was successfully performed. The patient¿s temperature continued to rise (104. 5 f), blood pressure increased (180/62mmhg), and the patient experienced nausea, headache, and dizziness. 911 was called and the patient was transported to the hospital and admitted. Additional information was received on 24 aug 2021 from the home therapy nurse (htn) who stated the patient presented to the emergency room with shortness of breath, cough, and general weakness, which had been present for the past week. The patient was treated empirically with antibiotics per hospital protocol, though blood culture results were negative, and white blood cell count was within normal limits. Patient has a history of noncompliance, noting two missed rounds of hemodialysis in the previous week, and a recent diabetic foot injury treated with two rounds of antibiotics. Per the htn, symptoms resolved, and the patient discharged himself from the hospital against medical advice on (b)(6) 2021 to continue treatments at the dialysis facility prior to returning to home hemodialysis.
 
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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 Key12459435
MDR Text Key271000763
Report Number3003464075-2021-00041
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number10677030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/13/2021 Patient Sequence Number: 1
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