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

Catalog Number 1407CA

Device Problems Device Inoperable (1663); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

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 instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported by the mcs coordinator that a patient called in and reported a "vad stop, change controller" alarm.He reported hearing a battery connect beep sporadically for about a week.At those times, there was nothing on the screen.When the patient heard the beep this time, the patient was instructed by the controller to change his controller.The patient changed the controller without incident.

Manufacturer Narrative

It was reported that the patient reported a "vad stop, change controller" alarm and  reported hearing 'battery connect' beeps sporadically.At those times there was nothing on the screen. 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 controller revealed that the device passed visual inspection and functional testing.The controller did not alarm a vad disconnect alarm when a driveline was connected to the controller.Additionally, the controller was able to properly alarm a vad disconnect alarm when the driveline was physically disconnected from the controller.The controller did not alarm sporadic beeps during testing; the controller was able to accept uninterrupted power from power sources connected to the controller.Log files analysis revealed that on (b)(6) 2017 at 11:52:53 a critical battery alarm was logged for bat219753.Shortly thereafter, at 11:53:29 the controller logged a vad disconnect alarm due to a physical disconnection of the driveline from the controller.The data logs indicate that at 11:39:52 hours, moments before the "critical battery" alarm, bat219753 was connected to ps1 with 94% rsoc and bat208209 was connected to ps2 with 96% rsoc.The battery connected to ps1 was driving the controller.This one was the last data entry. at 11:52:53, during the critical battery alarm, bat219753 went from 94% rsoc to 0%.These are events are most often related to communication errors, an internal investigation has being open.Analysis of the data files also revealed power switching events.These events may be due to communication errors and/or momentary disconnections between the controller and batteries.Momentary disconnections will result in an audible tone, or beep.Momentary disconnections are being addressed on an internal investigation.The alarm files did not reveal a controller fault/failed alarm that would of instructed the patient to exchange the controller.The most likely root cause of the reported vad stopped alarm can be attributed to a physical disconnection of the driveline from the controller.A possible root cause of the reported beeps can be attributed to momentary disconnections between the controller and batteries.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 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6413048
• MDR Text Key: 70319779
• Report Number: 3007042319-2017-00758
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 1407CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1