MAUDE Adverse Event Report: SUNSHINE HEART, INC. AQUADEX FLEXFLOW SYSTEM ULTRAFILTRATION SYSTEM

Catalog Number 114158

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Loss Of Pulse (2562)

Event Date 01/16/2017

Event Type  Death  

Manufacturer Narrative

Device analysis: the blood circuit set and console were returned for analysis. The console was inspected and tested upon return. Testing included simulated use bench testing for 2 days, challenge testing for 10 hours, and final release testing. Results for all tests met specification. Calibration settings of the sensors were also verified. The alarm log was downloaded and reviewed. Several alerts/alarms occurred during system set-up related to blood leak detected and air detected in the system. All alerts and alarms were responded to in accordance with the instructions for use and the remainder of the therapy proceeded unremarkably until the reported event occurred. The blood circuit set was visually inspected upon return. There was no evidence of blood in the ultrafiltration line or outside the filter housing and tubing. The results of the visual inspection resulted in no evidence of leaks or observed anomalies. The device history and servicing records were reviewed and no issues or discrepancies were noted that would have contributed to the reported event. The device met material, assembly, and quality control requirements. In conclusion, the aquadex flexflow console and blood circuit set met all specifications and performed as intended.

Event Description

It was reported that a patient expired during aquadex flexflow therapy. The patient began therapy via a central line at a fluid removal rate of 200 ml/hr. After approximately 20 minutes of therapy, the patient became hypotensive, experienced a pulseless electrical activity (pea) arrest and could not be resuscitated. A total of 90 cc of fluid was removed during therapy. Requests for additional information have been made, but none have yet been received.

• Brand Name: AQUADEX FLEXFLOW SYSTEM
• Type of Device: ULTRAFILTRATION SYSTEM
• Manufacturer (Section D): SUNSHINE HEART, INC.; 12988 valley view road; eden prairie MN 55344
• Manufacturer (Section G): SUNSHINE HEART, INC.; 12988 valley view road; eden prairie MN 55344
• Manufacturer Contact: megan brandt ; 12988 valley view road; eden prairie, mn 55344 ; 9523454206
• MDR Report Key: 6395134
• MDR Text Key: 69605524
• Report Number: 3007137787-2017-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: 114158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 03/10/2017 Patient Sequence Number: 1