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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 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.
 
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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 Key11744408
MDR Text Key247921169
Report Number11744408
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 04/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2021
Event Location Hospital
Date Report to Manufacturer04/29/2021
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

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