• 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 NX1000-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Dyspnea (1816); Paralysis (1997); Pneumonia (2011); Confusion/ Disorientation (2553); Unspecified Mental, Emotional or Behavioural Problem (4430)
Event Date 12/18/2020
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. Based on the available information, there is no indication that a malfunction occurred. A search of the complaint database revealed no other serious events associated with this device.
 
Event Description
A report was received on (b)(6) 2020 from the home therapy nurse (htn) of a (b)(6) year old female patient with a known medical history of asthma, diabetes, left lung lower lobectomy and end stage renal disease stating the patient experienced a stroke during hemodialysis therapy on (b)(6) 2020. Additional information was received on (b)(6) 2021 from the htn who stated that the patient was transported to hospital, having multiple syncopal episodes enroute and was admitted with shortness of breath, inability to move her left lower extremity and confusion. Examinations in the emergency department (ed) to establish a differential diagnosis included cranial and pulmonary ct scans both with and without contrast medium, perfusion head ct, electrocardiogram, chest xray and extensive laboratory testing including blood cultures. Compliance with medications taken prior to hospitalization could not be determined. Testing results showed no occlusion of the large cranial vessels and no intracranial hemorrhage. A small, distal pulmonary embolus of unspecified significance and origin was found as well as extensive atelectasis and pneumonia. Antibiotic therapy was initiated (ceftriaxone and azithromycin, nos) and the patient was transferred to the intensive care unit. Results of the ed workup led to the documented diagnoses of altered mental status, left leg weakness, pulmonary embolism and pneumonia. Details of the course of hospitalization and date of discharge were requested and were not provided. The htn stated that the physician considered the event unlikely related to the device or hemodialysis therapy.
 
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 Key11228779
MDR Text Key241236089
Report Number3003464075-2021-00002
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 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
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?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1
-
-