• 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 NX1000-3-A
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Anemia (1706); Fall (1848); Head Injury (1879); Swelling (2091); Dizziness (2194); Loss of consciousness (2418); Sweating (2444); Blood Loss (2597)
Event Date 12/21/2018
Event Type  Injury  
Manufacturer Narrative
No product was received for evaluation. A review of the device history record (dhr) of the reported serial number confirmed no related defects were found during the manufacturing and the device was released for distribution having met all product design requirements. (b)(4). Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on (b)(6) 2018 from a (b)(6)-year-old male with a medical history including anemia, hypertension and type ii diabetes who reported that he elected to remove more fluid than prescribed during a solo home hemodialysis treatment on (b)(6)2018 and he became sweaty, dizzy, lost consciousness, fell and hit his head. A large unspecified amount of blood was noted shortly after treatment (nos) around the hemodialysis device. Additional information was received from the home therapy nurse (htn) on (b)(6) 2018 stating the amount of blood loss could not be determined. The patient attended the hospital on (b)(6) 2018 where he received a blood transfusion for worsened anemia of 6. 9 g/dl (previous value not given). Mild right frontal scalp soft tissue swelling was evaluated via a ct scan which showed no acute intracranial abnormality and the patient was released without sequelae to continue 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 Key8241378
MDR Text Key132853697
Report Number3003464075-2019-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3-A
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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 Received12/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/11/2019 Patient Sequence Number: 1
-
-