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

Model Number 120100

Device Problems Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

Aquadex machine turned off (said "system failure" across screen. It instructed me to turn off for 5 seconds and turn back on. After it was turned off for 5 seconds and restarted, it did resume. I had to input my blood flow, uf, and hct max again as all these fields were blank when the machine turned back on. As far as i know this has only happened with our new (grey) aquadex machines. It has never happened to my knowledge with the older blue ones. After taking to staff, this has happened at least 3 times with the new grey aquadex machines. This is a recurring issue with the aquadex machines. The loaner machine was received monday and the pulled device was shipped back to chf (vendor). The only evaluation done by the onsite reps was to ship the equipment back, as of today we haven't received any other evaluation results from the vendor. There was no detectable harm.

• 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: 11744408
• MDR Text Key: 247921169
• Report Number: 11744408
• 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: 04/19/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 120100
• Device Catalogue Number: 120100
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2021
• 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?

• Type of Device Usage: Unkown