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U.S. Department of Health and Human Services

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

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CHF SOLUTIONS, INC. AQUADEX FLEXFLOW DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 114158
Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Event Description
Aquadex flexflow machine (tl-02596) consistently alarmed "infusion line disconnected", pu and pi pressures out of range. Patient was receiving/undergoing aquapheresis treatment when machine started to alarm, within 15mins of starting. Unable to solve problem. Within 15mins of aquapheresis initiation, patient's ij and femoral line pressures went out of range. Alarmed "infusion line disconnected", but all connections were tight. Aspirated and flushed both lines, no problems noted. But pu was still near -300 and pi ran negative, -11. It's possible that the filter was clotted, or it can be a machine defect. I'm not sure what to recommend as it could have been either a clotted filter, or a machine defect. Machine is pulled from different unit and brought back to unit, is tagged to be checked. Patient care manager (pcm) reached out to chf solution for the problem with the machine, according to chf from our statement, "the infusion line disconnect is a pressure related alarm does not only occur if the line is disconnected it changes with vessel size. " if patient was crying, their vessel size fluctuates. The console is not an issue per chf solution, we will still pull it out of service and send it out since it is a rental. This device was sent to the manufacturer. There was no detectable harm.
 
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Brand NameAQUADEX FLEXFLOW
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 Key11862722
MDR Text Key251976511
Report Number11862722
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 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number114158
Device Catalogue Number114158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/06/2021
Event Location No Information
Date Report to Manufacturer05/21/2021
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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