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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM Back to Search Results
Model Number CAR-172-C
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Tachycardia (2095)
Event Date 12/16/2017
Event Type  Injury  
Manufacturer Narrative
The device was not available for evaluation. A dhr review of the cartridge lot number confirmed no related defects were found during the manufacturing process, and the lot was released for distribution having met all product design requirements. The user guide includes allergic reaction as a potential risk associated with dialysis treatments and also includes warnings to monitor for potential allergic reactions. A review of the complaint database was performed for the involved cartridge lot number and there have been no other complaints of this type reported. Nxstage medical considers this report closed. No additional information will be provided. This report and the information contained herein is submitted to the food & drug administration under 21 cfr part 803 and represents the information available to the company at the time of the report.
 
Event Description
A report was received on 18-dec-2017 regarding a (b)(6) female patient who experienced a hypersensitivity reaction within 10 minutes of her first standard hemodialysis treatment on (b)(6) 2017. Symptoms included throat tightness, eye swelling and tachycardia. Hemodialysis therapy was terminated and symptoms improved after administration of 10 mg intravenous chlorphenamine.
 
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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 Key7163529
MDR Text Key96338580
Report Number3003464075-2018-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2018
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number60577027
Other Device ID Number+M535CAR172C0/$$0118605770278
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 Received12/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2016
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: 01/04/2018 Patient Sequence Number: 1
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