• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number NX1000-3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Weakness (2145)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative
A device serial number was not provided and the device was not returned for evaluation. Without a serial number, a review of the device history record (dhr) is unable to be performed. All product is released having met all manufacturing specifications and quality requirements. 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. Per the healthcare professional, the reported event is likely related to the patient''s comorbidities and recent episode of weakness. The diagnosis of ''small vessel stroke'' is compatible with complications of hypertension and unlikely the result of a dialysis treatment.
 
Event Description
A report was received on (b)(6) 2020 from a 62 year old male patient with a medical history of carcinoma, hypertension, previously suspected angina in (b)(6) 2020 (nos), gout, sleep apnea, and end stage renal disease, who stated he lost consciousness while terminating a standard home hemodialysis treatment and returning his blood manually on (b)(6) 2020. The patient stated he suffered a stroke and was admitted to hospital. Additional information was received on (b)(6) 2020 from the healthcare professional (hcp) stating the patient was admitted to hospital on (b)(6) 2020 with a diagnosis provided by a neurologist of small vessel stroke with ¿severe deficit of left arm and legs¿. Per the hcp, the event is likely related to the patient''s comorbidities and recent episode of weakness. The details of hemodialysis treatment and course of hospitalization were not provided. The patient was discharged to a rehabilitation facility on (b)(6) 2020.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10713174
MDR Text Key212348268
Report Number3003464075-2020-00070
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K122051
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 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/21/2020 Patient Sequence Number: 1
-
-