MAUDE Adverse Event Report: CHF SOLUTIONS, INC. AQUADEX FLEXFLOW SYSTEM; ULTRAFILTRATION SYSTEM

Model Number	UF 500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The uf 500 blood circuit was discarded by the facility and was not returned for failure analysis.Therefore, the root cause of the blood leak could not be determined.
Event or Problem Description
It was reported that during therapy with the aquadex flexflow system, a blood leak was detected.The blood leak occured within the uf 500 blood circuit.The facility reported that the blood leak occurred after two hours of circuit use.The uf 500 blood circuit was replaced with a new circuit and therapy was resumed.

• Brand Name: AQUADEX FLEXFLOW SYSTEM
• Common Device Name: ULTRAFILTRATION SYSTEM
• Manufacturer (Section D): CHF SOLUTIONS, INC.; 12988 valley view road; eden prairie MN 55344
• MDR Report Key: 7915531
• Report Number: 3007137787-2018-00003
• Device Sequence Number: 11137916
• Product Code: KDI
• UDI-Device Identifier: 07332414112387
• UDI-Public: (01)07332414112387(17)200321(10)7966
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K071854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2020
• Device Model Number: UF 500
• Device Catalogue Number: 114156 (A2000)
• Device Lot Number: 7966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 4