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

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.

• Brand Name: AQUADEX FLEXFLOW
• 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: 11862722
• MDR Text Key: 251976511
• Report Number: 11862722
• 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: 05/06/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 114158
• Device Catalogue Number: 114158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Event Location: No Information
• Date Report to Manufacturer: 05/21/2021
• 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