• 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 SAK-302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Sepsis (2067)
Event Date 02/12/2021
Event Type  Injury  
Manufacturer Narrative
The user stated that the device leaked due to compromised integrity of the dialysate sack. Per the htn, the involved product was discarded and was not available for evaluation. The nxstage user guide provides instructions and warnings to monitor for leaks, maintain aseptic technique and to prevent the risk of exposure to infectious diseases. All product is released meeting all quality criteria and manufacturing specifications. Biocompatibility of the device has been established.
 
Event Description
A report was received on 19 feb 2021 from the caregiver (cg) of a (b)(6) year old male patient with a medical history of glomerulonephritis and end stage renal disease, stating the patient experienced fever and was hospitalized following a hemodialysis treatment on (b)(6) 2021. Additional information was received on 22 feb 2021 from the home therapy nurse (htn) who stated the patient terminated treatment and was admitted to hospital with a diagnosis of sepsis on (b)(6) 2021. Blood cultures identified enterococcus gallinarum and no additional details of the hospitalization or treatment were 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
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key11474137
MDR Text Key239716657
Report Number3003464075-2021-00010
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K140571
Exemption Number5645646
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSAK-302
Device Catalogue NumberSAK-302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/12/2021 Patient Sequence Number: 1
-
-