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

Model Number 1420

Device Problems Device Alarm System (1012); No Display/Image (1183); Pumping Stopped (1503); Date/Time-Related Software Problem (2582); Power Problem (3010)

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

Event Date 05/23/2019

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: brand name: heartware ventricular assist system ¿ battery.Model #: 1650de, catalog #: 1650de, expiration date: 31-jan-2017, serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 31-jan-2016.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller displayed numerous critical battery alarms and several power disconnect and loss of power alarms which led to a ventricular assist device (vad) stop.The battery light indicators on the controller were not working and the date and time displayed were incorrect.It was also reported that a battery had a critical battery alarm and communication error.The controller was exchanged and the battery remains in use.No patient complications have been reported as a result of this event.

Event Description

It was further reported that five batteries and the controller ac adapter exhibited potential power switching.The power sources were serviced and remain in use.

Manufacturer Narrative

Other devices involved in this event: d1: heartware ventricular assist system ¿ battery d4: (b)(4).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.

Manufacturer Narrative

Product event summary: the controller was returned for evaluation.Five batteries ((b)(6) ) and one controller ac adapter ((b)(6) ) were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned controller revealed that the unit passed visual inspection.Functional testing revealed that the controller was unable to determine the capacity of the batteries connected to both power ports, causing the controller to trigger critical battery alarms.System running test revealed that the led lights on the controller front panel were not illuminating.Internal inspection of the controller revealed a damaged diode on the communication line.Additionally, it was observed that the integrated circuit responsible for the communication between the controller and batteries and connected to the real time clock was damaged.Log file analysis revealed that (b)(6) contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the alarm log file revealed thirty-one (31) critical battery alarms logged with an incorrect date stamp.Analysis of the event log file revealed thirteen (13) controller power up events logged with an incorrect date stamp.Analysis of the data log file did not reveal any premature power switching events within the analyzed period.A power source lubrication procedure was performed on associated power sources on 03/jun/2019.As a result, the reported loss of power, critical battery alarm, power disconnect alarm, display error and real time clock error events were confirmed; a suspected power switching event, however, could not be confirmed.Based on the log file analysis, the most likely root cause of the vad disconnect alarms may be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the critical battery alarms, display error and an incorrect date stamp can be attributed to the damaged diode on the communication line and damaged integrated circuit, likely due to a misalignment of the cac adapter on a power port of the controller, causing a voltage spike on the communication pin of the connector.A possible root cause of the losses 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.Other devices involved in this event: d1: heartware ventricular assist system ¿ battery serial #: (b)(6) h3: yes h6: fda method code(s): 4112, 4114 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial #: (b)(6) h3: yes h6: fda method code(s): 4112, 4114 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial #: (b)(6) h3: yes h6: fda method code(s): 4112, 4114 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial #: (b)(6) h3: yes h6: fda method code(s): 4112, 4114 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 d1: heartware ventricular assist system ¿ battery serial #: (b)(6) h3: yes h6: fda method code(s): 4112, 4114 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 d1: heartware ventricular assist system ¿ ac adapter serial #: cac092291 h3: yes h6: fda method code(s): 4112, 4114 h6: fda results code(s): 213 h6: fda conclusion code(s): 67 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.

Manufacturer Narrative

A supplemental report is being submitted as remedial action and correction number information was received.If new information is received, the file will be re-opened and a supplemental will be submitted.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: 8655297
• MDR Text Key: 146542508
• Report Number: 3007042319-2019-07126
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2020

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: 10/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/03/2019; 07/18/2019; 03/06/2020
• Supplement Dates FDA Received: 06/12/2019; 07/23/2019; 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1428-2020
• Patient Sequence Number: 1
• Treatment: 1104 VAD; 1104 VAD
• Patient Age: 55 YR
• Patient Weight: 72