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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 Patient Device Interaction Problem (4001)
Patient Problem Exsanguination (1841)
Event Date 03/10/2022
Event Type  Death  
Event Description
A report was received on 21 mar 2022 from the home therapy nurse (htn) of a (b)(6) male patient with a complex medical history including end stage renal disease, who stated the patient expired approximately twenty five minutes into hemodialysis treatment on (b)(6) 2022. Additional information was received on 22 mar 2022 from the home therapy nurse (htn) who stated emergency medical services were called and found the patient supine, pulseless, and apneic, surrounded by a ¿large amount of blood¿. Lifesaving measures were unsuccessful, and the patient was pronounced deceased at an unspecified time. Per the htn, the patient's death was most likely related to intentional dislodgment of his dialysis needle and unrelated to the device.
 
Manufacturer Narrative
The involved cycler was not received for evaluation. 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. There was no indication of a device malfunction from the available information. The nxstage system one user guide states that a trained and qualified person must observe all treatments so that harmful conditions can be responded to promptly. 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 Key14117307
MDR Text Key289319436
Report Number3003464075-2022-00011
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 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2022
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2017
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: 04/15/2022 Patient Sequence Number: 1
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