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U.S. Department of Health and Human Services

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

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CHF SOLUTIONS, INC. AQUADEX SMARTFLOW CONSOLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NameAQUADEX SMARTFLOW CONSOLE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CHF SOLUTIONS, INC.
12988 valley view rd
eden prairie MN 55344
MDR Report Key11677536
MDR Text Key245807413
Report Number11677536
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number120100
Device Catalogue Number120100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/13/2021
Event Location Hospital
Date Report to Manufacturer04/16/2021
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

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