• 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-505
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Emotional Changes (1831); Rash (2033); Respiratory Distress (2045); Urticaria (2278)
Event Date 02/27/2018
Event Type  Injury  
Manufacturer Narrative
The cartridge was not returned for evaluation and a lot number was not provided. Without a lot number, a device history review (dhr) could not be performed. An evaluation of the cartridge was not possible. Biocompatibility has been established. There is no information to indicate that a malfunction occurred. Allergic or adverse reactions are known risks of hemodialysis. The nxstage system one user guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and the instructions for use include warnings to observe the patient and monitor physical status for potential complications. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 5 apr 2018 from an intensive care nurse regarding a (b)(6) female with a medical history that included systemic lupus, synovitis and a known hypersensitivity to polysulfone dialyzers, who experienced symptoms while receiving continuous veno-venous hemodialysis (cvvh). The patient was premedicated with intravenous solumedrol/100 and benadryl/50 prior to therapy with the nxstage system one. Two hours after treatment commenced, the patient exhibited hives, rash, respiratory distress, tachypnea with wheezing, increased oxygen requirement and agitation. Treatment was changed to a dialyzer from a different manufacturer and no further issues were reported.
 
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 Key7426018
MDR Text Key105327735
Report Number3003464075-2018-00018
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCAR-505
Device Catalogue NumberCAR-505
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 Received04/05/2018
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: 04/12/2018 Patient Sequence Number: 1
-
-