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

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.

• Brand Name: NXSTAGE SYSTEM ONE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE MEDICAL, INC.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 8335447
• MDR Text Key: 136048047
• Report Number: 8335447
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 02/13/2019
• 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 FDA: 01/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2019
• 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