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

Model Number 1403US

Device Problems Device Inoperable (1663); Use of Device Problem (1670)

Patient Problem Loss of consciousness (2418)

Event Date 03/22/2018

Event Type  Injury  

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.Other devices involved in this event: heartware ventricular assist system ¿ battery, battery / (b)(4) / model #: 1650 / expiration date: 2016-05-31, udi #: (b)(4), device evaluation anticipated, but not yet begun, mfg date: 2015-05-31, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was found unconscious and unresponsive at their home with only one battery connected to the controller.The battery charge was depleted, resulting in a ventricular assist device (vad) pump stop for approximately twenty-one hours.The battery had a critical battery alarm when the charge was below ten percent.The patient was hospitalized.When two other fully-charged batteries were connected to the controller, the pump restarted and operated within normal parameters.The vad, controller and battery remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The controller and battery were not returned for evaluation.Log file analysis revealed that the controller in use during the reported event 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 revealed two (2) critical battery and six (6) controller fault alarms.The critical battery alarms were the result of the battery depleting below 10% relative state of charge (rsoc).A controller fault alarm will occur if the battery is approaching 0% rsoc.Log file analysis also revealed seven (7) controller power up events beginning (b)(6) 2018 at 22:45:22.The controller was without power for 21 hours, 8 minutes, and 48 seconds in total.As a result, the reported event was confirmed.The most likely root cause of the critical battery, controller fault alarms and loss of power can be attributed to the patient allowing batteries to deplete below 10%.The batteries likely recovered enough charge to start the con troller again, but quickly depleted, causing additional controller power up events.An internal investigation was initiated to capture events involving the controller losing power.Additional products: battery/bat300749.Yes.(b)(4).

Manufacturer Narrative

Corrections: product event summary: the controller and battery were not returned for evaluation.Log file analysis revealed that the controller in use during the reported event contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the event log file revealed a controller power-up event on 22/mar/2018 at 18:33:45.The controller was without power for 14 seconds.A review of the alarm file revealed two (2) critical battery and six (6) controller fault alarms logged since 03/apr/2018.The critical battery alarms were the result of the remaining connected battery depleting below 10% relative state of charge (rsoc).A controller fault alarm will occur if the battery is approaching 0% rsoc.A review of the event file revealed seven (7) controller power-up events recorded since (b)(6) 2018.As a result, the reported event was confirmed.A possible root cause of the loss of power recorded on 22/mar/2018 can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.The most likely root cause of the critical battery alarms, controller fault alarms, and losses of power on and after (b)(6) 2018 can be attributed to the patient allowing the remaining connected battery to deplete below 10%.The battery likely recovered enough charge to start the controller again, but quickly depleted, causi ng additional controller power up events.An internal investigation was initiated to capture events involving the controller losing power.Additional products: catalog #: 1650 / serial #: (b)(4) device evaluated by mfr: yes , fda conclusion code(s): 19 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7450736
• MDR Text Key: 106194217
• Report Number: 3007042319-2018-01545
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 1403US
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD; 1103 VAD
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR