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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 Problems Death (1802); Exsanguination (1841)
Event Date 08/13/2018
Event Type  Death  
Manufacturer Narrative
The cycler was received for evaluation and was found to be functioning as designed and intended. A review of the device history record (dhr) for the cycler was conducted and revealed the product was released having met all design and manufacturing specifications and requirements. There is no information to indicate that a malfunction occurred. (b)(4). Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received on 13 aug 2018 from a nurse regarding a (b)(6) male patient who performed home hemodialysis on an unspecified date and expired on or around (b)(6) 2018. On (b)(6) 2018 the patient was found disconnected from the device and deceased, with approximately 2l of blood on the floor. The cause of death was reported as exsanguination. No additional information 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
9786875276
MDR Report Key7846417
MDR Text Key119240581
Report Number3003464075-2018-00035
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 01/01/2005,09/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberNX1000-3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2018
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 Received08/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2016
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: 09/05/2018 Patient Sequence Number: 1
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