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

Model Number 1420

Device Problems Disconnection (1171); Device Inoperable (1663); Connection Problem (2900); Power Problem (3010)

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

Event Date 06/01/2018

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.Battery / (b)(4)/ model #: 1650 / expiration date: 2017-03-31.Udi #: (b)(4).Device evaluation anticipated, but not yet begun.Mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650 / expiration date: 2017-03-31.Udi #: (b)(4).Device evaluation anticipated, but not yet begun.Mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650 / expiration date: 2017-03-31.Udi #: (b)(4).Device evaluation anticipated, but not yet begun.Mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650 / expiration date: 2017-03-31.Udi #: (b)(4).Device evaluation anticipated, but not yet begun.Mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system ¿ controller ac adapter.Controller ac adapter / (b)(4) / model #: 1425us / udi #: asku.Device evaluation anticipated, but not yet begun.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that four batteries exhibited power switching, that the controller lost power, and that the external protective wire coverings on the batteries and the controller ac adapter were damaged.It was also reported that a double disconnect of controller power sources occurred.The controller, ac adapter, and four batteries were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: one (1) controller, four (4) batteries, and one (1) controller ac adapter were not returned for evaluation.As a result, the reported "battery and adapter external wire covering damage" could not be confirmed due to insufficient evidence.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 several premature power switching events that were due to momentary disconnections involving all four batteries.Analysis of the event files revealed four (4) controller power-ups with their associated motor starts on 2018-may-10, 2018-may-12, 2018-may-15 and 2018-jun-01 at 16:44:37, 05:53:45, 11:10:56 and 04:48:31, respectively.Momentary disconnections were observed prior to the second and fourth losses of power.The controller was without power for 11 seconds, 9 seconds, 14 seconds, and 13 seconds, respectively.As a result, the reported power switching and loss of power events were confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the damaged battery and ac adapter cables can be attributed, but not limited, to wear and/or to the handling of the devices.The most likely root cause of the premature power switching event can be attributed to momentary disconnections 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.An internal investigation evaluated momentary disconnections.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

H10 product event summary, h10 additional products product event summary: one (1) controller (con307024), four (4) batteries (bat318447, bat318281, bat318251, bat317160), and one (1) controller ac adapter (cac103713) were not returned for evaluation.As a result, the reported "battery and adapter external wire covering damage" could not be confirmed due to insufficient evidence.Log file analysis revealed that the controller, con307024, 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 several premature power switching events that were due to momentary disconnections involving bat318447, bat318281, bat318251, and bat317160.Additionally, data log file revealed a relative state of charge (rsoc) between 101-201 involving bat318251, and bat317160, which is indicative of a communication error and alarm log file revealed a critical battery alarm involving bat318281, due to communication error.Analysis of the event files revealed four (4) controller power-ups with their associated motor starts on 10-may-2018, 12-may-2018, 15-may-2018 and 01-jun-2018 at 16:44:37, 05:53:45, 11:10:56 and 04:48:31, respectively.Momentary disconnections were observed prior to the second and fourth losses of power.The controller was without power for 11 seconds, 9 seconds, 14 seconds, and 13 seconds, respectively.There is no evidence that the lubrication servicing was performed on the reported power sources.As a result, the reported power switching and loss of power events were confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the damaged battery and ac adapter cables can be attributed, but not limited, to wear and/or to the handling of the devices.The most likely root cause of the premature power switching event can be attributed to momentary disconnections 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.The most likely root cause of the observed critical battery alarm and rsoc values between 101-201 can be attributed to communication errors between the controller and batteries.An internal investigation was initiated to capture events involving the controller losing power.An internal investigation evaluated momentary disconnections.Additional products: battery bat318281 h6: fda conclusion code(s): 4307 battery bat318251 h6: fda conclusion code(s): 4307 battery bat317160 h6: fda conclusion code(s): 4307 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.

Event Description

It was also reported that after log file review, one of the batteries was indicated to have had a critical battery alarm and two of the batteries were indicated to have had a communication error.

• 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: 7627566
• MDR Text Key: 112475348
• Report Number: 3007042319-2018-02666
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2019
• Patient Sequence Number: 1
• Treatment: 1103 VAD
• Patient Age: 41 YR