• 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 CAR-170-C
Device Problem Improper Flow or Infusion (2954)
Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880); High Blood Pressure/ Hypertension (1908)
Event Date 07/16/2019
Event Type  Injury  
Manufacturer Narrative
The involved cartridge was returned for evaluation and found to be functioning as designed and intended. A review of the device history record (dhr) for the involved cartridge lot was conducted which confirmed the product met all quality criteria and manufacturing specifications prior to release. Biocompatibility of the device has been established.
 
Event Description
A report was received on (b)(6) 2019 from the home therapy nurse (htn) of a (b)(6) year old male patient, stating a few minutes after initiating a hemodialysis treatment the patient became symptomatic with chest pain, shortness of breath, headache, and hypertension. Blood was present in the effluent line and treatment was terminated without rinseback. Additional information was received 17 jul 2019 - 12 aug 2019 from the htn stating the patient was transported to hospital via ambulance and admitted 16 - 18 jul 2019, with an unspecified discharge diagnosis. Although requested, no further information was provided.
 
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 Key8894463
MDR Text Key154395722
Report Number3003464075-2019-00039
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
Type of Report Initial
Report Date 01/01/2005,08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2021
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Is the Reporter a Health Professional? Yes
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 Received07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/14/2019 Patient Sequence Number: 1
-
-