MAUDE Adverse Event Report: NXSTAGE MEDICAL, INC. NXSTAGE CYCLER S MACHINE; NXSTAGE HOME HEMODIALYSIS MACHINE

Model Number MX1000-1

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 10/16/2018

Event Type  Death  

Event Description

The following info was reported to the home hemodialysis rn after the pt expired.Prior to initiation of the home hemodialysis treatment, the caregiver reported she attempted to prime a cartridge.Caregiver reports she was unable to complete priming due to the machine resetting the priming time and not progressing to the testing phase.A second cartridge was primed without difficulty, the machine passed testing, so the treatment was initiated.Upon initiation of treatment, b/p: 166/68; pulse 60.The caregiver reported approx 20-30 mins into treatment, the arterial pressure alarmed and was indicating '0' pressure.The caregiver repositioned the arterial needle and stated she was unable to reset the machine, so she could not continue the treatment.Reportedly no air was observed in the cartridge or the dialysis lines.The treatment was stopped and blood was returned manually.Reportedly both the pt and caregiver heard a sound.As reported by the caregiver, both she and the pt were unsure if the sound came from the machine or not.The pt then became unresponsive.Cpr was initiated by the caregiver; ems was called and the pt was transported to the hospital, where he expired.

• Brand Name: NXSTAGE CYCLER S MACHINE
• Type of Device: NXSTAGE HOME HEMODIALYSIS MACHINE
• Manufacturer (Section D): NXSTAGE MEDICAL, INC. ; lawrence MA 01843
• MDR Report Key: 8033792
• MDR Text Key: 126092630
• Report Number: 8033792
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MX1000-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2018
• Distributor Facility Aware Date: 10/16/2018
• Event Location: Home
• Date Report to Manufacturer: 10/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 72