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

Catalog Number 114158 (A1100)

Device Problem Defective Alarm (1014)

Patient Problem Blood Loss (2597)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Device returned for investigation.Investigation is in process.Follow-up will be submitted pending results of the investigation.

Event Description

It was reported that during therapy with the aquadex flexflow system, the console did not give a blood leak detected alarm.

Event Description

It was reported that during therapy with the aquadex flexflow system, the console did not give a blood leak detected alarm.

Manufacturer Narrative

Suspect device was returned for analysis.There were no signs of damage and the device was verified to be within calibration as-found.The aquadex console blood leak detector was tested as-found by simulating therapy and alarmed as designed when blood samples ranging from 1%-29% hematocrit were passed through the detector.An in-house control console blood leak detector was used to confirm the analysis.Analysis of the device was unable to confirm the reported condition.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported event could not be determined.

• Brand Name: AQUADEX FLEXFLOW SYSTEM
• Type of Device: ULTRAFILTRATION SYSTEM
• Manufacturer (Section D): CHF SOLUTIONS, INC.; 12988 valley view road; eden prairie MN 55344
• MDR Report Key: 7975716
• MDR Text Key: 124568432
• Report Number: 3007137787-2018-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K071854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114158 (A1100)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 4