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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 NX1000-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apnea (1720); Death (1802); Exsanguination (1841); Cognitive Changes (2551); Loss Of Pulse (2562)
Event Date 11/07/2019
Event Type  Death  
Manufacturer Narrative
The cycler was received for evaluation and passed all testing with no trouble found. 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. A review of the log file for the date of the event was consistent with needle dislodgement and there was no device malfunction. 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).
 
Event Description
A report was received on (b)(6) 2019 from the home therapy nurse (htn) regarding a (b)(6) year old male with end-stage renal disease, type ii diabetes, hypertension, peripheral vascular disease, coronary artery disease, mitral regurgitation, and hernia repair, who expired during a home hemodialysis treatment on (b)(6) 2019. Additional information was received on 18-26 nov 2019 from the home therapy manager (htm) stating the patient treated without the care partner present for an unspecified amount of time and was found pulseless and apneic with an estimated 3-4l blood loss. Resuscitation included chest compressions, intubation, multiple doses of iv epinephrine and attempts at defibrillation, intravenous amiodarone 450mg, calcium chloride 1g, bicarb 1amp and intraosseous saline 250ml. Resuscitative measures were unsuccessful and the patient was pronounced deceased at 1650hrs on (b)(6) 2019. Per physician, the cartridge venous line had been disconnected and the dialysis port was open with the cause of death suspected suicide from hemorrhage due to their mental health status after being denied a kidney transplant.
 
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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
9784505276
MDR Report Key9453513
MDR Text Key170339253
Report Number3003464075-2019-00075
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K050525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberNX1000-1
Device Catalogue NumberNXSTAGE SYSTEM ONE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2019
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 Received11/12/2019
Date Device Manufactured08/28/2013
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/11/2019 Patient Sequence Number: 1
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