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

Model Number 1103

Device Problems Failure to Pump (1502); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2022

Event Type  malfunction  

Event Description

It was reported that the patient disconnected their power accidentally.When the patient replaced the power to the controller, the ventricular assist device (vad) didn't restart and the the controller read vad stopped.The patient changed their controller out for their backup, and the vad restarted.The vad remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Additional products: heartware ventricular assist system ¿ model #: 1420/ catalog #: 1420/ expiration date: 31-dec-2019 / serial or lot#: (b)(4) udi #: (b)(4) d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: (b)(4) 2018 h5: no h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: img code(s): g04035.Fda device code(s): (b)(4).Fda method code(s): fda results code(s).Fda conclusion code(s).Investigation of this event is pending and a supplemental report will be sent upon its completion.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 is being submitted for additional information.Product event summary: the controller (b)(4) was returned for evaluation.The ventricular assist device (b)(4) was not returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned controller revealed that the device passed visual inspection and functional testing.Analysis of the available event log file pertaining to (b)(4) revealed that the controller was not in use prior to the reported event and was most likely the patient¿s back up controller.Log file analysis associated with (b)(4) revealed one (1) controller power-up without associated motor start event logged on 03-sep-2022 at 05:59:57.The data point recorded in the controller's internal logs prior to the controller power-up revealed that bat905696 was connected to power port one (1) with 31% relative state of charge (rsoc) and bat933816 was connected to power port two (2) with 96% rsoc.The data point recorded in the controller's internal logs after the controller power-up revealed that bat905696 was connected to power port one (1) and a controller power adapter was connected to power port two ( 2).The controller was without power for 13 seconds.No anomalies were recorded leading up to the loss of power.Analysis of the alarm log file pertaining to (b)(4) revealed that a vad stopped alarm was logged on 03-sep-2022 at 06:00:47 due to a failure of the pump to restart after multiple attempts.Two (2) vad disconnect alarms were logged at 06:00:54 and 06:02:27.The first vad disconnect alarm was most likely a false alarm, given that the speed recorded at the onset of the alarm was higher than the set speed.This indicates that a possible loss of synchronization of commutation occurred.Commutation is the process of switching winding current to generate motion.If the pump rotational speed drifts higher than the speed set-point, the motor voltage will decrease to achieve the desired speed.However, if there is no change to the speed (speed reading remains frozen), the voltage will continue to decrease to zero.This likely caused the current to decrease to zero, triggering a vad disconnect alarm, even if the driveline was still ph ysically connected to the controller.The second vad disconnect alarm indicated a physical disconnection of the driveline from the controller, likely due to the reported controller exchange.Of note, it was reported that the pump was able to restart after the controller exchange.As a result, the reported event was confirmed.The most likely root cause of the loss of power can be attributed to a disconnection of both power sources by the patient as described in the event details.Capa pr00551638 is investigating controller losses of power.Possible causes of the vad disconnect alarms can be attributed to a loss of synchronization of commutation leading to a false vad disconnect alarm, and/or a physical disconnection of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.The most likely root cause of the vad stopped alarm can be attributed to a failure of the pump to restart after several attempts.(b)(4) was in scope of fca cvg-21-q3-21.Capa pr00502194 is investigating pump failures to restart.Additional products: (b)(4) ¿ controller 2.0 d9: yes, return date: 13-sep-2022 h3: yes dev rtn to mfr? yes h6: img code(s): g0200701 h6: fda method code(s): b01, b15 h6: fda results code(s): c19, c02, c23 h6: fda conclusion code(s): d02, d10, d11 investigation of this event is completed and the file will be closed.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.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 - PUMP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15392313
• MDR Text Key: 306355680
• Report Number: 3007042319-2022-07211
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Date Device Manufactured: 12/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 105 KG