• 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 Diarrhea (1811); Nausea (1970); Vomiting (2144); Electrolyte Imbalance (2196)
Event Date 04/13/2017
Event Type  Injury  
Manufacturer Narrative
The device has not been received for investigation. There is no indication that the device was related to the reported event. The user guide warns: hemodialysis may result in significant changes in the blood concentration of electrolytes and glucose and in the patient¿s volume status. Appropriate monitoring of the patient¿s hemodynamic, fluid, electrolyte, and acid-base balance should be performed regularly, per physician orders, to ensure appropriate response to therapy. Failure to do so could result in inappropriate therapy for the patient.
 
Event Description
A report was received on (b)(6) 2017 regarding a (b)(6) female home hemodialysis patient who experienced elevated potassium (k+), elevated blood urea nitrogen (bun), diarrhea, nausea and vomiting. The patient was admitted to the hospital on (b)(6) 2017. While hospitalized the patient received dialysis treatments (nos). The patient recovered without sequelae and was released on (b)(6) 2017. The discharge diagnosis was hyperkalemia.
 
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
9786874700
MDR Report Key6518199
MDR Text Key73604947
Report Number3003464075-2017-00025
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/25/2017 Patient Sequence Number: 1
-
-