• 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 SLE-3010M3096
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Respiratory Distress (2045); Swelling (2091); Loss of consciousness (2418); Respiratory Failure (2484)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
The cartridge was not retained for investigation. The design history file for the cartridge lot number was reviewed and met all requirements in the manufacturing process prior to release with no related defects. All available information supports that the product was functioning as designed and there was no malfunction. The user guide includes allergic reaction as a potential risk associated with dialysis treatments and also includes warnings to monitor for potential allergic reactions. Biocompatibility of the device has been established. (b)(4) considers this report closed. No additional information will be provided. (b)(4).
 
Event Description
A report was received of a (b)(6) male patient who experienced shortness of breath, acute respiratory failure with airway edema, lip and tonsillar swelling during hemodialysis treatment in center. Symptoms developed 17 minutes after treatment commenced on (b)(6) 2017. The patient became unresponsive to verbal command and sternal rub. Benadryl, 50mg, intravenous was administered. The patient was transported to the hospital where he was intubated and mechanically ventilated. Epinephrine (route and dose unspecified), solumedrol 125mg and famotidine were administered. The patient was transferred to intensive care and was discharged from the hospital on (b)(6) 2017. The physician summary stated the patient symptoms were inconsistent with a diagnosis of anaphylaxis alone. The patient''s lisinopril was discontinued as a potential risk factor.
 
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 Key6352329
MDR Text Key68102753
Report Number2919260-2017-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2017
Device Model NumberSLE-3010M3096
Device Catalogue NumberSTREAMLINE EXPRESS, 8MM, GAMMA
Device Lot Number60956001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2016
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: 02/23/2017 Patient Sequence Number: 1
Treatment
LISINOPRIL
-
-