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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 NX1000-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/29/2020
Event Type  Death  
Manufacturer Narrative
The device was received for evaluation and successfully passed the prime and alarms test 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. +m535nx1000160/$$+736885/16d20181115s.
 
Event Description
A report was received on 01 oct 2020 from the home therapy nurse (htn) of a (b)(6) year old male patient with multiple comorbidities and end stage renal disease, stating that the patient expired during a home hemodialysis session (b)(6) 2020. Additional information was received on 05 oct 2020 from the home therapy nurse (htn) who stated that the patient's cause of death is unknown.
 
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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
9784505276
MDR Report Key10739514
MDR Text Key213167384
Report Number3003464075-2020-00072
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K170469
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-16
Device Catalogue NumberCYCLER VERSIHD, NO NIBP MODULE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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