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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Extubate (2402)
Event Date 11/17/2019
Event Type  Death  
Manufacturer Narrative
All product is released meeting all product design specifications and quality criteria. The available information does not indicate there was a device malfunction or that the patient death was attributed to nxstage product or therapy.
 
Event Description
A report was received on 18 nov 2019 from the home therapy nurse regarding patient a (b)(6) year old male with a medical history of hypertension, hydrocephalus, spina bifida and end stage renal disease who became unresponsive at an unspecified time while performing a home hemodialysis treatment without a caregiver present on (b)(6) 2019. The patient later expired at the hospital. Additional information was received on 25 nov 2019 from the home therapy nurse, who stated the caregiver found the patient unconscious and not breathing at an unspecified time during therapy on (b)(6) 2019. The caregiver commenced cpr and called ems who found the patient asystolic and continued resuscitative efforts including epinephrine enroute to the hospital. On arrival at the hospital the patient was given iv calcium gluconate and iv sodium bicarbonate, 2mg naloxone, epinephrine, was intubated and defibrillated once a shockable rhythm returned. The patient regained spontaneous circulation for an unspecified amount of time before deteriorating and subsequently expired due to cardiac arrest on (b)(6) 2019.
 
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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 Key9403757
MDR Text Key168880210
Report Number3003464075-2019-00072
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
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 01/01/2005,01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
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? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received12/31/2019
Date Device Manufactured02/02/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/03/2019 Patient Sequence Number: 1
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