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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Malaise (2359); Loss of consciousness (2418)
Event Date 03/09/2021
Event Type  Death  
Manufacturer Narrative
The device was received for evaluation and successfully passed the testing, confirming proper functionality of the device and sensors. Available log files were retrieved and analyzed which showed device performance was without incident and was unremarkable. A review of the device history record confirmed the product was released meeting all product design specifications and quality criteria. All information supports the device was functioning as designed and intended with no malfunction. Udi: (b)(4).
 
Event Description
A report was received on 09 mar 2021 from the nurse of a (b)(6) male with a medical history including hypertension, type ii diabetes, chronic systolic heart failure, morbid obesity, anemia, heart disease, pulmonary hypertension and end stage renal disease, who stated the patient coded during a hemodialysis treatment on (b)(6) 2021. Additional information was received on 10 mar 2021 from the nurse stating approximately one minute into treatment the patient stated he did not feel well and was short of breath. Treatment was terminated, 2l nasal oxygen was applied and intravenous saline was administered. Within minutes the patient became unresponsive, was placed in trendelenburg position, and an automated external defibrillator advised compressions with no shock advised. 911 was called and compressions commenced until emergency medical services (ems) arrived on the scene. Resuscitation efforts were unsuccessful, and the patient expired after being transported to the hospital, time not provided. Per the htn, the cause of death was undetermined.
 
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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
nxstage medical, inc
350 merrimack street
lawrence, MA 01843
9784505276
MDR Report Key11580949
MDR Text Key242676224
Report Number3003464075-2021-00013
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported123
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberCYC-D2E W/ SERVICE COMPUTER
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/29/2021 Patient Sequence Number: 1
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