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	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned for investigation.Investigation is in process.Follow-up will be submitted pending results of the investigation.
Event or Problem Description
It was reported that during therapy with the aquadex flexflow system, a blood leak was detected.The blood leak occurred within the uf 500 blood circuit.The facility reported that the blood leak occurred within 20 minutes of circuit use.The uf 500 blood circuit was replaced with a new circuit and therapy was resumed.
Event or Problem Description
It was reported that during therapy with the aquadex flexflow system, a blood leak was detected.The blood leak occurred within the uf 500 blood circuit.The facility reported that the blood leak occurred within 20 minutes of circuit use.The uf 500 blood circuit was replaced with a new circuit and therapy was resumed.
Additional Manufacturer Narrative
Suspect device was returned for analysis.A visual examination confirmed the blood leak within the circuit.There were no signs of damage to the circuit.The filter was removed from the circuit and tested for leaks.A single fiber was identified as leaking (out of approximately 900 fibers).The suspect fiber was isolated and injected with dye to determine location once the filter case was removed.The filter case was removed, and the suspect fiber located.The suspect fiber was confirmed to be broken.Analysis of the device confirmed a filter fiber break and associated blood leak contained within the circuit.Testing of devices from other lots was unable to recreate the reported event.The manufacturing batch record review confirmed that the suspect device met all material, assembly and performance specifications.The cause of the reported event could not be determined.

• 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: 7975671
• Report Number: 3007137787-2018-00005
• Device Sequence Number: 1681873
• 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,Followup
• Report Date (Section B): 11/16/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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