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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 NX1000-3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 03/02/2020
Event Type  Death  
Manufacturer Narrative
There was no indication of a device malfunction from the available information. A review of the device history record confirmed the product was released meeting all product design specifications and quality criteria. (b)(4).
 
Event Description
A report was received on (b)(6) 2020 from the home therapy nurse (htn) regarding a (b)(6)male with multiple comorbidities including recent hospitalization for bacteremia, who was performing home hemodialysis without a caregiver present and found unresponsive at an unspecified time on (b)(6) 2020. Emergency personnel attended and pronounced the patient deceased upon arrival. Additional information was received 03-25 mar 2020 from the htn and physician stating the cause of death has not been determined.
 
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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 Key9891677
MDR Text Key185472968
Report Number3003464075-2020-00021
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberNX1000-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/27/2020 Patient Sequence Number: 1
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