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

Model Number HOME HD MACHINE MANUFACTURER: NXSTAGE

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

(b)(6) 2018, a home hemodialysis (hd) patient's husband reported to (b)(6) medical care technical service that he is receiving notifications for software updates for a fresenius 2008k@home machine, and his wife (the patient) is deceased and requested that the notifications from fresenius to stop.Follow-up information from the patient's associated fresenius kidney care dialysis clinic nurse revealed that the patient had died some years ago and was using nxstage products prior to her death.The nurse stated that while using nxstage, it is believed the patient was hospitalized and eventually discharged to a nursing home for poor health.The patient was using nxstage while in the hospital and at the nursing home.It is unknown if the patient was dialyzing at the time of death or prior to death.The patient had been discharged from the (b)(6) clinic on (b)(6) 2015 to affiliated home dialysis company.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NXSTAGE
• MDR Report Key: 17523508
• MDR Text Key: 321076959
• Report Number: MW5130456
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: HOME HD MACHINE MANUFACTURER: NXSTAGE
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1