MAUDE Adverse Event Report: CHF SOLUTIONS, INC. AQUADEX SMARTFLOW CONSOLE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 120100

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2021

Event Type  malfunction  

Event Description

Dialysis nurse was at the bedside, no one was touching the machine and the "system failure" popped up to turn off the machine and wait 5 seconds before turning it back on.Patient treatment was done.Patient care manager reached out to chf solution again for the same issue but this time no one touched the machine.Chf solution sales representative will talk to engineering.Machine was pulled out of service after treatment and waiting for chf solution to provide information.There was no harm in this event.This has been a recurring issue.

• Brand Name: AQUADEX SMARTFLOW CONSOLE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CHF SOLUTIONS, INC.; 12988 valley view rd; eden prairie MN 55344
• MDR Report Key: 12031664
• MDR Text Key: 257177781
• Report Number: 12031664
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 120100
• Device Catalogue Number: 120100
• 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: 06/01/2021
• Date Report to Manufacturer: 06/21/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA