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

Catalog Number 1403US

Device Problems Image Display Error/Artifact (1304); Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 10/08/2016

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 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.The hvad controller is a microprocessor unit that controls and manages the heartware system operation.It sends power and operating signals to the blood pump and collects information from the pump.The controller's internal, non-replaceable, rechargeable battery is used to power an audible "no power" alarm when both power sources are disconnected.Inability to read the display associated with an alarm may result in no action or the wrong or inappropriate action taken in response to critical alarms.The hvad controller requires two power sources for safe operation: either two batteries, or one battery and an ac adapter or dc adapter.The instructions for use (ifu) provides guidance regarding controller visual and auditory alarms.The "no power" alarm provides a loud continuous auditory alarm that users are unable to mute.The ifu explains that this critical alarm indicates that the controller is not providing power to the pump and that the pump has stopped.They are instructed that potential actions to resolve the issue include connecting two new power sources, exchanging the controller and contacting heartware clinical support.The ifu and patient manual explain the correct method of connecting to and disconnecting from the power sources and the controller to prevent damage to either the power source connections or the controller power ports.According to the ifu and patient manual, users are instructed to return any damaged components to heartware.If the controller is only connected to one power source, the controller will function, but will sound an alarm after twenty seconds.In addition, the user is cautioned to always have a backup controller available and programmed identically to the primary controller.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

A report was received that a patient noted a no power alarm that could not be silenced while he was at home. this event was also associated with half of the controller led display screen appearing blank. the patient initially attempted to change out his power sources but this was unsuccessful at resolving the issue.The patient and the vad team also noted that one of the power ports was loose on the controller. the site reported that the user did not use excessive force when connecting his power sources and that the controller had not been dropped.Two power sources were  securely connected to the controller at the time of the event.The controller was exchanged with issue resolution in the outpatient clinic with no reported patient consequence.

Manufacturer Narrative

The reported loose components for the returned controller were confirmed during evaluation of the device.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Review of the log files reveals a controller power-up event on the reported event date (b)(6) 2016) at 16:10:03.Prior to this event, the controller was connected to (b)(4) with 97% and 68% remaining capacities respectively.Following the event, the controller was connected to (b)(4) with 97% and 64% remaining capacities respectively.The most likely root cause of the reported event can be attributed to a double disconnection of external power sources from the controller.Analysis revealed that the device failed visual inspection due to loose connectors and displaced gaskets at power ports 1 and 2 of the controller.No issues were observed regarding the controller's display.The most likely root cause of the reported event can be attributed to a double disconnection of external power sources from the controller.A possible root cause of the loose connectors may be attributed to a shift in the manufacturing process.Heartware has an open internal investigation to evaluate the anomalies of loose connectors.The controller's display functioned as expected.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60 avenue; miami lakes FL 33014 3105
• MDR Report Key: 6115705
• MDR Text Key: 60438834
• Report Number: 3007042319-2016-04185
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2016
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0005-2017
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 105