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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 Problems Disconnection (1171); Fluid Leak (1250)
Patient Problems Fall (1848); Hemorrhage/Bleeding (1888)
Event Date 12/08/2021
Event Type  Death  
Event Description
A report was received on 09 dec 2021 from the home therapy nurse (htn) of a (b)(6)female with a medical history including end stage renal disease approved for performing solo home hemodialysis treatment, who stated the patient passed away approximately an hour into a home hemodialysis treatment on (b)(6) 2021. Additional information was received on 17 dec 2021 from the htn who stated the patient was found face down on the floor at an unspecified time during treatment with the arterial blood line disconnected and surrounded by blood (amount not provided). Emergency medical services were called, cardiopulmonary resuscitation was performed, a defibrillator was applied, and medication (nos) was given. Per the htn the cause of death has not been determined.
 
Manufacturer Narrative
The device was received for evaluation and successfully passed testing with no malfunction found. Available log files were retrieved and analyzed which showed the cycler performed as intended and alarmed appropriately when the alarm conditions were present. A review of the device history record (dhr) was conducted which confirmed that the device met all quality criteria and manufacturing specifications prior to release. The nxstage system one user guide supplement for solo home hemodialysis outlines risks, warnings, and requirements for the solo home hemodialysis patient. Udi: (b)(4).
 
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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
MDR Report Key13170494
MDR Text Key283265808
Report Number3003464075-2022-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNX1000-3
Device Catalogue NumberCHRONIC HI-FLOW CYCLER
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2018
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: 01/05/2022 Patient Sequence Number: 1
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