• 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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Reaction (2414); Loss of consciousness (2418); Chest Tightness/Pressure (2463)
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) for the involved lot was conducted which revealed the product met all quality criteria and manufacturing specifications prior to release. Biocompatibility of the device has been established. There is no evidence to suggest that a product malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage system one user's guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and also includes warnings to observe the patient and monitor physical status for potential complications.
 
Event Description
A report was received on (b)(6) 2018 from the home therapy nurse (htn) regarding gg, a (b)(6) year old male with multiple comorbidities and medical history significant for recent dyspnoea, chest discomfort (nos), and intradialytic hypotension with loss of consciousness four (4) days prior, who became symptomatic 6 mins after commencing a standard hemodialysis treatment in a dialysis facility on (b)(6) 2018. Symptoms included shortness of breath, chest discomfort, hypotension and loss of consciousness. Rinseback was performed to return blood in the extracorporeal circuit and emergency services were called. Patient symptoms improved with use of supplemental oxygen and the patient was hospitalized. Hemodialysis using a system from a different manufacturer was performed in hospital and the patient was discharged on (b)(6) 2018 to continue hemodialysis treatments with the alternate device. Per the physician the patient had an atypical reaction to the dialyzer.
 
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 Key8116208
MDR Text Key128874629
Report Number3003464075-2018-00065
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 01/01/2005,11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2019
Device Model NumberCAR-170-C
Device Catalogue NumberCAR-170-C
Device Lot Number71277029
Was Device Available for Evaluation? No
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 Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/29/2018 Patient Sequence Number: 1
-
-