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

Model Number 120100

Device Problems Coagulation in Device or Device Ingredient (1096); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Event Description

Patient was on aquapheresis - goal end time was in evening.Before the goal end time, there was an alarm on the pump to empty the uf bag, which i was about to do.And then a few seconds later that was very loud and repetitive alarm with a screen that said "system failure: turn console off, wait 5 seconds, then turn it on again.If message persists, contact customer service." machine was turned off as well as the prismasol and heparin.Md and dialysis rn contacted regarding this situation immediately.Decision was made to end aquapheresis early for the day, due to blood clotting already starting in the circuit.Dialysis rn called aquadex representative to inquire further.Machine was removed from patient room to avoid further errors like this in the future.The device was evaluated by the vendor onsite at facility and it was decided to be shipped back to manufacturer, (b)(4), once a loaner device was made available to us.The loaner was just received, and the device involved in this event was shipped back to chf today.There was no detectable harm in this event.There have been recurring problems with aquadex machines.

• 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: 11677536
• MDR Text Key: 245807413
• Report Number: 11677536
• 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: 04/13/2021

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?: Yes
• Device Operator: No Information
• Device Model Number: 120100
• Device Catalogue Number: 120100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA