• 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-500
Device Problems Fluid Leak (1250); Therapeutic or Diagnostic Output Failure (3023); Air/Gas in Device (4062)
Patient Problem Cardiac Arrest (1762)
Event Date 03/08/2021
Event Type  Injury  
Manufacturer Narrative
The cartridge was not available for evaluation. A review of the device history record (dhr) was conducted for the reported lot number and confirmed the product was released for distribution having met quality and manufacturing specifications and requirements. The nxstage system one user guide and car-500 instructions for use (ifu) provide information and warnings for use of the device. The user guide states "do not attach ancillary devices that can restrict blood flow, such as stopcocks, to the patient lines" as well as "failure to make the proper connections may cause compromised treatment, blood loss, injury or death". A trained and qualified person must observe all treatments, check the system for blood and fluid leaks during treatment, and pay close attention to the blood lines and access connections ensuring all manual connections are secure and fluid tight.
 
Event Description
A report was received on (b)(6) 2021 from the health professional of a (b)(6) critical care patient with multiple comorbidities and pneumonia secondary to covid-19, stating the patient coded while connected to unspecified equipment for extracorporeal membrane oxygenation (ecmo) and performing continuous veno-venous hemofiltration (cvvh) therapy with the nxstage device on (b)(6) 2021. Additional information was received on 22 apr 2021 from the cardiovascular intensive care unit nurse manager (nm) stating that the cvvh was connected to the patient via dedicated access that lost functionality and cvvh was switched to run via the ecmo circuit. Once connected to the ecmo, a "large amount" of air was entrained and an unspecified amount of blood was noted on the floor. Air removal was successful. After the code the patient received two units of packed red blood cells, was neurologically intact and following commands.
 
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
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key11757221
MDR Text Key248401477
Report Number3003464075-2021-00019
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-500
Device Catalogue NumberCAR-500
Device Lot Number01278003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2021
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: 04/30/2021 Patient Sequence Number: 1
-
-