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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Vomiting (2144)
Event Date 11/01/2017
Event Type  Injury  
Manufacturer Narrative
The cartridge was not retained for investigation. The device history record was reviewed and no related defects were found during the manufacturing of this lot. Biocompatibility of the device has been established. Allergic or adverse reactions are known risks of hemodialysis. The nxstage one user guide includes allergic or adverse reaction as potential risks associated with dialysis treatments and also includes 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 (b)(6) 2017 from a home therapy nurse regarding a (b)(6) female patient who became symptomatic approximately one hour into a standard in-center hemodialysis treatment on (b)(6) 2017. The patient developed symptoms of hypotension, vomiting and feeling cold. A saline bolus was administered and the symptoms resolved with no additional medical intervention.
 
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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 Key7048484
MDR Text Key92617287
Report Number3003464075-2017-00049
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K140526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2019
Device Model NumberCAR-172-C
Device Catalogue NumberCAR-172-C
Device Lot Number70877007
Other Device ID Number+M535CAR172C0/$$021970877007C
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 Received11/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 11/21/2017 Patient Sequence Number: 1
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