MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1104

Device Problems Image Display Error/Artifact (1304); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Approximately six months and two weeks post heartware lvad implantation, it was reported that the patient underwent an elective controller exchange due to a faulty controller display.There was no reported patient injury as a result of this event.Investigation is ongoing.

Manufacturer Narrative

The device is available for evaluation, but has not been received by the manufacturer.Additional information will be submitted within thirty (30) days of receipt.

Manufacturer Narrative

The heartware ventricular assist device (vad) is used for treatment not diagnosis.The reported event indicates an issue with the performance of the controller.The device related to the reported event was exchanged without incident and there was no reported patient injury.A controller was returned to heartware for evaluation; various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.The controller passed visual inspection; functional testing revealed that the device would boot up to a vad stop alarm indicating that the device would not run a pump motor; additionally the 'no power' alarm did not sound.Further testing revealed that the alarm failed due to a bad nimh battery on the power board wherein the battery was leaking corrosion material onto itself and other components on the controller board.It is likely that the controller's inability to run the pump is a result of the damage and contamination the circuit board and electrical components from the corroded battery.The confirmed malfunction is related to the reported event.The event describes that the controller is not able to show the flow.The malfunction caused the controller to not recognize connected power sources; this normally results in a 'no power' alarm and the display shutting down.However, testing revealed that the controller's internal nimh battery, used to power the alarm when no power sources are connected, failed.As a result, the reported event describing that the controller is not able to show the flow is confirmed.The most likely root cause of the reported event is due to corrosion of controller's internal battery which rendered controller alarms nonfunctional in addition to causing the contamination to internal electrical components resulting in the device's inability to function.This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Per the instructions for use (ifu): patients are instructed to always keep a back-up controller available at all times, beyond the primary controller that is currently in use.Patients are instructed to contact the treating facility if they receive any of a list of certain alarms heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Heartware is submitting this report as a result of remediation activities related to fda warning letter fla-14-14, dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 310
• Manufacturer Contact: kathleen jacobson ; 14420 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641562
• MDR Report Key: 4112941
• MDR Text Key: 4937817
• Report Number: 3007042319-2014-00981
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 09/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4) - CONTROLLER