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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INCHEARTWARE® VENTRICULAR ASSIST SYSTEMCIRCULATORY ASSIST SYSTEM, CONTROLLER

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HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER   Back to Search Results
Catalog Number 1401US
Event Date 02/25/2013
Event Type  Death   Patient Outcome  Death
Manufacturer Narrative

Correction made to reflect the "type of reportable event" based on the severity of the case.

 
Manufacturer Narrative

The device has been received and is awaiting further analysis. Additional information will be submitted within thirty (30) days of receipt.

 
Event Description

This event involves a patient who experienced controller alarms approximately thirty-four months post heartware lvad implantation and subsequently expired at a local hospital. A family member came to the patient house were she was found unresponsive with the lvad controller alarming. The emergency services were activated and cardio-pulmonary resuscitation was performed. The patient was taken to a local non-vad implanting facility where she expired shortly after arrival. A preliminary log file analysis revealed that shortly after changing her batteries, the patient experienced a controller fault alarm followed by a sustained drop in flow and power. This condition persisted for approximately three hours before intervention. An autopsy will be performed but the results have not been provided as of the date of this report. The device has been returned to the manufacturer for evaluation.

 
Manufacturer Narrative

Following the submission of the initial mdr report the suspect controller was returned to heartware for investigation. Various analyses were conducted and reviewed in order to evaluate the performance of the controller in relation to the reported event. These included clinical evaluation, review of manufacturing documentation, visual and functional examination, and review of controller log files. Functional testing of the returned controller showed that the device (including motor control circuits) performed all functions as intended within specification and with no fault alarms or errors. The controller power and driveline connections were tested and were confirmed to be secure and properly functioning. Review of the controller log data file indicated that both batteries were changed just prior to the reported event. The log files further indicated that at the time of the event there was a condition present in which the motor control software was no longer driving the pump's motor controller circuit; this is referred to as "loss of commutation". When commutation is halted, the pump stops. Review of the controller log alarm and event files showed a low flow alarm followed by a controller fault alarm (6-seconds later). The patient was found alone and unresponsive with the controller alarming approximately three hours post event. Log analysis confirmed the reported event that the pump had stopped. The exact cause of the loss of commutation cannot be conclusively determined; however, we suspect that an electrostatic discharge (esd) through the exposed controller power ports during battery replacement caused or contributed to data corruption in the pump motor controller resulting in loss of commutation. Additional information: the post mortem medical report provided by the hospital indicated that the patient suffered from ehlers-danlos syndrome with significant aortic and mitral valve insufficiency which greatly contributed to the risk of mortality in the event of a pump stop.

 
Manufacturer Narrative

 
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Brand NameHEARTWARE® VENTRICULAR ASSIST SYSTEM
Type of DeviceCIRCULATORY ASSIST SYSTEM, CONTROLLER
Manufacturer (Section F)
HEARTWARE, INC
14000 nw 57th court
miami lakes FL 33014 3105
Manufacturer (Section D)
HEARTWARE, INC
14000 nw 57th court
miami lakes FL 33014 3105
Manufacturer (Section G)
HEARTWARE, INC
14420 nw 60th avenue
miami lakes FL 33014 3105
Manufacturer Contact
miguel sosa
14420 nw 60th avenue
miami lakes , FL 33014-3105
(305) 364 -1555
Device Event Key3052643
MDR Report Key3025979
Event Key2922493
Report Number3007042319-2013-00042
Device Sequence Number1
Product CodeDSQ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Health Professional
Remedial Action Notification
Type of Report Followup,Followup
Report Date 02/26/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number1401US
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2013
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received02/26/2013
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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