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

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.

• 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: 11648119
• MDR Text Key: 244862737
• Report Number: 11648119
• 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: 04/01/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/12/2021
• 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?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2021
• 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