MAUDE Adverse Event Report: NYTONE NYTONE BEDWETTING ALARM; ENURESIS ALARM

Model Number NY92978

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Exsanguination (1841); Myocardial Infarction (1969)

Event Date 10/03/2018

Event Type  Death  

Event Description

On the morning of (b)(6) 2018 during a nocturnal home hemodialysis treatment, the pt's enuresis alarm sounded, waking the pt's wife.This was approx 3.5 hours into the scheduled 5 hour treatment.The pt's wife reported that upon hearing the alarm, she reached over to touch her husband, who was cold to touch.She got up, turned on the light and saw blood on the bed and floor.She called 911.She stated she clamped the venous line.Reportedly, when she clamped the venous line, the venous fistula needle popped out.Ems arrived and started cpr, which was stopped per wife's request.The policed arrived, who called the pt's physician.The pt's wife reported that the pt was transported to the mortuary with the enuresis device still on his arm.Upon review of the dialysis treatment record, it was noted that numerous dialysis machine alarms requiring the pt reset the alarm before treatment could be resumed occurred throughout the entire treatment.The pt's wife reported to the home therapies staff that the venous needle was re-positioned during the treatment, time unk.Pt received 8000 unit heparin bolus upon initiation of treatment, and 1000 units/hour heparin infusion during the treatment.

• Brand Name: NYTONE BEDWETTING ALARM
• Type of Device: ENURESIS ALARM
• Manufacturer (Section D): NYTONE; bluffdale UT 84065
• MDR Report Key: 7957660
• MDR Text Key: 123513904
• Report Number: 7957660
• Device Sequence Number: 1
• Product Code: KPN
• 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: 10/09/2018,10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NY92978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2018
• Distributor Facility Aware Date: 09/25/2018
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 10/09/2018
• 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: 72 YR
• Patient Weight: 119