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U.S. Department of Health and Human Services

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

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SUNSHINE HEART, INC. AQUADEX FLEXFLOW SYSTEM ULTRAFILTRATION SYSTEM Back to Search Results
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.
 
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Brand NameAQUADEX FLEXFLOW SYSTEM
Type of DeviceULTRAFILTRATION 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 Key6395134
MDR Text Key69605524
Report Number3007137787-2017-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071854
Number of Events Reported1
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 Received03/10/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number114158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2009
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
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