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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-A
Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Patient Problem Exsanguination (1841)
Event Date 03/19/2021
Event Type  Death  
Manufacturer Narrative
The involved device was not received for evaluation. A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release. Based on the available information, there is no evidence to indicate that a malfunction occurred. A search of the complaint database revealed no other serious events associated with this device. Udi: (b)(4).
 
Event Description
A report was received on 25 mar 2021 from the home therapy manager (htm) of a (b)(6) male patient with a medical history of diabetes and end stage renal disease, stating the patient expired during a hemodialysis treatment on (b)(6) 2021. Additional information was received on 31 mar 2021 from the home therapy nurse (htn) stating that the patient "pulled out his needles on dialysis" and the cause of death is exsanguination. No other details of the event were provided and no information was received to suggest the patients death was attributed to nxstage product or therapy.
 
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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 Key11649903
MDR Text Key244924392
Report Number3003464075-2021-00015
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K122051
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 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3-A
Device Catalogue NumberCHRONIC HI-FLOW CYCLER, ROHS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2019
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: 04/12/2021 Patient Sequence Number: 1
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