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

Model Number 1420

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

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

Event Date 05/05/2018

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 #: 1650de / expiration date: 2018-10-31.Udi #: (b)(4).Return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2017-10-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-10-31.Udi #: (b)(4).Return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2017-10-31.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-06-30.Udi #: (b)(4).Return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2017-06-30.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30.Udi #: (b)(4).Return date: 2018-05-23.Device evaluation anticipated, but not yet begun.Mfg date: 2017-09-30.(b)(4).Heartware ventricular assist system ¿ battery.Battery / (b)(4) / model #: 1650de / expiration date: 2018-07-31.Udi #: asku.Device evaluation anticipated, but not yet begun.Mfg date: 2017-07-31.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was power switching with the controller and five batteries.After another power switching incident, a red alarm occurred and then the display of the controller went blank.The patient changed both batteries.The controller and batteries were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that there was power switching with four batteries.

Manufacturer Narrative

Product event summary: the controller ((b)(4)), four (4) batteries ((b)(4)), and one controller ac adapter ((b)(4)) were returned for evaluation.One battery ((b)(4)) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of the returned devices revealed that all units passed visual examination and functional testing.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.Log file analysis did not reveal any premature power switching events during the analyzed period.As a result, the reported power switching event could not be confirmed.Analysis of the log files revealed a controller power up event on (b)(6) 2018 at 18:44:00.The data point prior to the loss of power revealed that (b)(4) was connected to power port one (1) and (b)(4) was connected to power port two (2) with 23% relative state of charge (rsoc).Battery (b)(4) experienced momentary disconnections leading up to the loss of power.The data point recorded after the loss of power revealed that (b)(4) was connected to power port (1) and (b)(4) was connected to power port two (2).The controller was without power for 10 seconds.A loss of power will cause the controller display to go blank and a loud, continuous alarm will sound.During power up, the controller performs a self-testing sequence, identified when the front panel battery and alarm led indicators turn green and red.This could explain the ¿red alarm¿ observed by the patient.As a result, the reported loss of power was confirmed.The most likely root cause of the reported loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one power source.An internal investigation was initiated to capture events involving the controller losing power.An internal investigation evaluated momentary disconnections.Additional products: battery / (b)(4); device evaluated by mfr: yes; battery / (b)(4); device evaluated by mfr: yes; battery / (b)(4); device evaluated by mfr: yes; battery / (b)(4); device evaluated by mfr: yes; battery / (b)(4); device evaluated by mfr: yes; controller ac adapter / (b)(4); device evaluated by mfr: yes.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.

Event Description

It was also reported that there was power switching with the controller ac adapter.The controller ac adapter was taken out of service.

Manufacturer Narrative

Corrections: b5, h10: d1, d4, d10, h3, h4, h5 other devices involved in this event: d1: heartware ventricular assist system ¿ controller ac adapter d4: controller ac adapter / (b)(4) / model #: 1430de / expiration date: unknown udi #: (b)(4).D10: yes, return date: 2018-05-23 h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unknown h5: no 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: 7567089
• MDR Text Key: 110084106
• Report Number: 3007042319-2018-02216
• Device Sequence Number: 1
• Product Code: DSQ
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: 1104 VAD