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

Model Number 1420-CONTROLLER

Device Problems No Audible Alarm (1019); Disconnection (1171); No Display/Image (1183); Battery Problem (2885); Power Problem (3010)

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

Event Date 06/19/2018

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.Other devices involved in this event: heartware ventricular assist system ¿ battery / (b)(4)/ model #: 1650- / expiration date: 2016-10-31 udi #: (b)(4), return date: 2018-06-28, device evaluation anticipated, but not yet begun mfg date: 2015-10-31 (b)(4).Heartware ventricular assist system ¿ battery / (b)(4)/ model #: 1650- / expiration date: 2016-09-30 udi #: (b)(4), return date: 2018-06-28 device evaluation anticipated, but not yet begun mfg date: 2015-09-30 (b)(4).Heartware ventricular assist system ¿ battery / (b)(4)/ model #: 1650- / expiration date: 2016-09-30 udi #: (b)(4), return date: 2018-06-28, device evaluation anticipated, but not yet begun mfg date: 2015-09-30 (b)(4).Heartware ventricular assist system ¿ battery/ (b)(4)/ model #: 1650- / expiration date: 2016-09-30 udi #: (b)(4), return date: 2018-06-28, device evaluation anticipated, but not yet begun mfg date: 2015-09-30 (b)(4).Heartware ventricular assist system ¿ battery / (b)(4)/ model #: 1650- / expiration date: 2016-09-30 udi (b)(4), return date: 2018-06-28 h3 device evaluation anticipated, but not yet begun mfg date: 2015-09-30 (b)(4).Heartware ventricular assist system ¿ battery / (b)(4)/ model #: 1650de / expiration date: 2018-11-30 udi #: (b)(4), return date: 2018-06-28 device evaluation anticipated, but not yet begun mfg date: 2017-11-30 (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient disconnected the only power source connected to the controller resulting in loss of power to the controller, no audible alarms, and a blank display screen.It was also reported that the patient experienced power switching between multiple battery sources.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Manufacturer Narrative

Product event summary: the controller and six batteries were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the controller and batteries in relation to the reported event.Failure analysis of (b)(4) revealed that the devices passed visual examination and functional testing.Failure analysis of (b)(4) revealed that the batteries passed functional testing; visual inspection revealed an illegible release indicator on the output cable of both batteries.This is an additional observation not related to the reported event, likely due to wear and/or improper handling.Failure analysis revealed that the controller passed functional testing.The "no power" alarm functioned as expected; therefore, the reported ¿no audible alarms¿ event could not be confirmed.Visual inspection revealed a crack on a corner of the controller housing.An internal visual inspection did not reveal fluid ingress.The crack finding is not related to the reported event and is likely due to the handling of the device.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 a premature power switching event due to a communication error involving (b)(4) and several premature switching events due to momentary disconnections involving (b)(4).Analysis of the event files also revealed two controller power up events.Loss of power events are associated with a blank display screen, as reported in the event details.The data point from the controller's internal logs logged prior to the first loss of power revealed that (b)(4) was connected to power port one (1) with 48% relative state of charge (rsoc) and (b)(4) was connected to power port two (2) with 24% rsoc.The data point after the controller power up event revealed that the (b)(4) was connected to power port one (1) with 47% rsoc and (b)(4) was connected to power port two (2) with 99% rsoc.The controller was without power for 11 seconds.The data point logged before the second loss of power revealed that (b)(4) was connected on power port 1 with 96% rsoc and (b)(4) was connected on power port 2 with 61% rsoc.The data point after the controller power up event revealed that (b)(4) was connected on power port 1 with 96% rsoc and (b)(4) was connected on power port 2 with 97% rsoc.The controller was without power for 13 seconds.Several momentary disconnections were logged in the periods leading up to the power loss events.As a result, the reported power switching event and loss of power event were confirmed.Based on the log file analysis, the most likely root cause of the premature power switching event can be attributed to momentary disconnections and communication errors 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 one or both power sources.An internal investigation was initiated to capture events involving the controller losing power.Momentary disconnections was investigated internally.(b)(4).Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7683615
• MDR Text Key: 114048694
• Report Number: 3007042319-2018-02996
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 1420-CONTROLLER
• Device Catalogue Number: 1420-CONTROLLER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 06/20/2018; 08/08/2018
• Supplement Dates FDA Received: 09/25/2018; 10/05/2018
• 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: 56 YR
• Patient Weight: 83