• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CHF SOLUTIONS INC. AQUADEX FLEXFLOW DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 114158
Device Problems Device Alarm System (1012); Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 03/13/2021
Event Type  malfunction  
Event Description
Blood leak in aquadex circuit noted by pink tinged effluent. Using aquadex 1 and aquadex cartridge lot # 20871. 51 minutes after treatment on time, after running aquapheresis treatment, pink tinged effluent in the effluent bag noted. There was no blood leak error message from aquadex machine, pu pressure
=
300. Picture sent to doctor. Per doctor, stop heparin. Personnel came to bedside, recommended treatment stopped. Terminated treatment 1 hour and 13 minutes after start. Device sales representative from chf solutions also notified as machine did not alarm "blood leak detected. " machine checked and blood leak detector was enabled. Blood leak strips used and detected blood leak. Per device sales representative sometimes the alarm safety checks don't occur when the "help prime" function is not used. Prompts allow machine to do all the self tests. Charge nurse came to help re-prime second set - unknowingly used same lot. Followed all prompts on "help prime" function. Treatment reinitiated with new circuit pu pressures within normal limits @ 48 at initiation. Noted light pink tinged effluent again. Heparin stopped after 20 minutes after initiation. Doctor was notified. Decision was made to terminate treatment. Device sales representative from chf solutions notified again of blood leak issue. Cartridge same lot number, same machine. Machine to be pulled out of service. Both blood cartridge circuits saved. Will use different machine and lot with next treatment. Follow up about why alarms did not trigger. Ctbe (clinical tech and biomed engineer) manager - followed up with ctbe dialysis technician - the device involved was removed from patient use and sent back to the vendor for evaluation. A new aquadex (model - smart flow) was installed for use. No patient care downtime occurred and patient risk has been mitigated. Manager reached out to chf solution for testing the defected devices. There were no issues with the device, blood leak alarm passed. Okay to use back in-service. Medical director aware of the pink tinged in drain bag, aware that this is not a device and most likely patient. The aquadex cartridge are also removed and replaced with new lot #. This device has been sent to the manufacturer. There was no detectable harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11648119
MDR Text Key244862737
Report Number11648119
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 04/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2021
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2021
Event Location Hospital
Date Report to Manufacturer04/12/2021
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

-
-