MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problems Low Audible Alarm (1016); Device Inoperable (1663); Connection Problem (2900); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller exhibited power switching and beeping followed by a ventricular assist device (vad) stop.It was also reported that the controller alarms were low volume and almost inaudible.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device revealed that the unit had a foreign label that was obstructing the gore-tex membrane.The gore-tex membrane, which allows air to penetrate the controller but not fluid ingress, enables equalization of pressure and ensures proper loudness of all alarms.This obstruction prevents the speaker from moving sufficiently to produce the required loudness.Opening and closing the controller case returned the volume of high priority alarms to specification limits.As a result, the reported low sound event was confirmed.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15 minute interval.Analysis of the data log files revealed several premature power switching events that were due to momentary disconnections.Momentary disconnection will result in an audible tone or "beep".As a result, the reported power switching and ¿beeping¿ events were confirmed.Additionally five (5) controller power-ups with their associated motor starts were logged from (b)(6) 2018 through (b)(6) 2018.Several momentary disconnections were recorded leading up to the losses of power.The controller was without power for 12 seconds, 9 seconds, 12 seconds, 10 seconds, and 8 seconds respectively.The most likely root cause of the reported low sound event can be attributed to an obstruction of the gore-tex membrane.The most likely root cause of the premature power switching and ¿beeping¿ events can be attributed to momentary disconnections between the controller and batteries.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on both power sources.An internal investigation was initiated to capture events involving the controller losing power.An internal investigation evaluated momentary disconnections.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7648417
• MDR Text Key: 112708996
• Report Number: 3007042319-2018-02776
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 32 YR