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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 Dizziness (2194); Loss of consciousness (2418); Shaking/Tremors (2515)
Event Date 02/25/2019
Event Type  Injury  
Manufacturer Narrative
The cycler was not provided for evaluation. A review of the device history record (dhr) of the reported serial number confirmed the device was released for distribution having met all product design requirements. Udi for nx1000-1: (b)(4). Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2019 from a (b)(6) male with multiple comorbidities including congestive heart failure, aortic stenosis, permanent pacemaker and hypertension who stated he felt dizzy, passed out and experienced tremors on regaining consciousness during a standard hemodialysis treatment on (b)(6) 2019. The patient stated that he had experienced the symptoms when increasing the blood flow rate, had rinsed back the circuit of blood and called emergency services who transported him to hospital. Additional information was received on (b)(6) 2019 from the home therapy nurse (htn) stating the patient was hospitalized from (b)(6) 2019. The hospital discharge summary received on 1 mar 2019 revealed the patient had been evaluated via chest x-ray and chest ct for a pulmonary embolus, with inconclusive findings. Testing for peripheral deep vein thrombosis was negative. Dialysis therapy was provided in the hospital without event and the patient was discharged (b)(6) 2019 with no further treatment or symptoms reported.
 
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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 Key8409784
MDR Text Key138458684
Report Number3003464075-2019-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/01/2005,03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberNX1000-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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 Received02/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/11/2019 Patient Sequence Number: 1
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