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

Model Number 1420-CONTROLLER

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Connection Problem (2900); Power Problem (3010)

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

Event Date 06/06/2018

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 was prematurely power switching and experienced power disconnect alarm with loss of power.The controller remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the controller was not returned for evaluation.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.A review of the alarm file did not reveal any power disconnect alarms.As a result, the reported "power disconnect alarm" event could not be confirmed.Analysis of the data log file revealed several premature power switching events that were due to momentary disconnections and communication error, thus confirming the reported power switching event.Analysis of the event file revealed one controller power up event and two controller power up events.The data points before the two controller power up events revealed several momentary disconnections leading up to the power loss events.As a result, the reported loss of power was confirmed.A power source lubrication procedure was performed on all associated power sources to mitigate the reported conditions.The most likely root cause of the reported premature power switching event can be attributed to momentary disconnections and communication errors between the controller and batteries.The patient may have perceived the momentary disconnections as the reported "power disconnect alarm," as momentary disconnections will result in an audible tone.A possible root cause of the reported loss of power may be attributed to a disconnection of both power sources from the controller and/or to an intermittent disconnection on one or both power sources.An internal investigation was initiated to capture events involving the controller losing power.Momentary disconnections were investigated internally.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This event was assessed and is being reported as part of a retrospective review of log file data.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7658251
• MDR Text Key: 113017963
• Report Number: 3007042319-2018-02827
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: 00888707000475
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 1420-CONTROLLER
• Device Catalogue Number: 1420-CONTROLLER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD; (B)(4)
• Patient Age: 70 YR