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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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NXSTAGE MEDICAL, INC. NXSTAGE SYSTEM ONE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Circuit Failure (1089); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2019
Event Type  malfunction  
Event Description
The crrt machine was set up in the hallway and had it in recirculation. I brought the machine into the room and plugged it into one of the red outlets at the head of the bed. The iv pumps were plugged into a plug in near the window and therefore we thought it was safe. Unfortunately, the breaker tripped and sent a surge to the crrt. When we flipped the breaker and turned the crrt back on it immediately had a red alarm #502. The circulator would not allow me to hit the yellow silence button, the red stop button or any button. We turned the circulator off then back on and the #502 alarm persisted. Therefore, i called the 1-866# and the tech told me that the surge had most likely 'fried' it. He instructed me to turn the machine off and put in a work order. He also gave me a case # and instructed me to tell you that you need to call into nxstage and give them this case number. They will then send a service tech here to take the machine apart and repair it. But you'll need that case # when you call. I requested to put a work order in for this machine.
 
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Brand NameNXSTAGE SYSTEM ONE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
NXSTAGE MEDICAL, INC.
350 merrimack st
lawrence MA 01843
MDR Report Key8335447
MDR Text Key136048047
Report Number8335447
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2019
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2019
Event Location Hospital
Date Report to Manufacturer02/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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