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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 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.
 
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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 Key12031664
MDR Text Key257177781
Report Number12031664
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 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2021
Event Location No Information
Date Report to Manufacturer06/21/2021
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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