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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 Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Exsanguination (1841)
Event Date 01/31/2017
Event Type  Death  
Manufacturer Narrative
There is no information to indicate that a malfunction occurred. The nxstage one user guide warns the user that slow fluid or blood leaks from loose connections, faulty components, venous access disconnection, vascular needle dislodgement or other potential causes may not be detected. It further warns to keep vascular access sites and cartridge connections visible throughout treatment. A trained and qualified person must monitor all treatments so that alarms and harmful conditions can be responded to promptly. A patient should not dialyze alone, even if they are trained and qualified. The cartridge was not retained for investigation and the log files were not sent for review. A lot number was not provided. All available information supports that the product was functioning as designed and there was no malfunction. Nxstage medical considers this report closed. No additional information will be provided.
 
Event Description
A report was received of a (b)(6) female patient with unknown comorbidities who expired while performing routine hemodialysis treatment at home alone. She was found unresponsive with the cycler alarming with a large unspecified quantity of blood noted in the chair. Rescue efforts including cpr were unsuccessful and the patient expired. The cause of death was listed by the coroner as exsanguination.
 
Manufacturer Narrative
Follow-up information was received from the home therapy nurse (htn) on april 7, 2017. The htn stated a delivery person for the dialysis center arrived at the patient¿s home at approximately 12:00 pm on (b)(6), 2017. The delivery person stated the patient was in a chair holding the access sites of her fistula to stop them from bleeding and the cycler was alarming. The patient was conscious and verbally communicative, she stated she was okay but felt tired. On (b)(6) 2017 the patient¿s emergency contact found the patient unresponsive in her chair surrounded by a large amount of blood. She was not connected to the nxstage system one. The log files for nxstage system one cycler serial # (b)(4) were evaluated. According to the log files the system was functioning as designed and intended and there was no device malfunction. Both the log file analysis and follow-up information received from the home therapy nurse on april 7, 2017, indicate that the patient was not connected to the nxstage system one at the time of death. No further information is expected.
 
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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
9786874700
MDR Report Key6369945
MDR Text Key68664129
Report Number3003464075-2017-00010
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,Followup
Report Date 03/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2017
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?
Event Location No Information
Date Manufacturer Received04/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2015
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: 03/01/2017 Patient Sequence Number: 1
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