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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 NX1000-1
Device Problem Insufficient Information (3190)
Patient Problems Arrhythmia (1721); Dyspnea (1816); Reaction (2414); No Code Available (3191)
Event Date 09/06/2017
Event Type  Injury  
Manufacturer Narrative
The available information does not indicate that there was a device malfunction. A device history review (dhr) of the equipment involved in this event showed that there were no defects during the manufacturing process. Though requested, additional information was not provided.
 
Event Description
A report was received from the facility center nurse on (b)(6) 2017 that a (b)(6) female patient with a history of cardiac disease and dementia had a reaction while receiving standard hemodialysis therapy. Additional information provided by the nurse revealed that the patient had experienced shortness of breath, irregular heart rhythm and chest heaviness within the first two minutes of commencing treatment. The patient received oxygen, was admitted to hospital and discharged on (b)(6) 2017. No information regarding treatment while hospitalized or a discharge diagnosis is available.
 
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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 Key6891605
MDR Text Key87321240
Report Number3003464075-2017-00045
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E
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 Received09/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/25/2017 Patient Sequence Number: 1
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