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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503)
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| Patient Problems
Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Tachycardia (2095); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 07/21/2022 |
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Event Type
Death
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Event Description
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It was reported that the patient complained of bent pins and unstable/poor mechanical connections on the power port of the controller in use.The patient was advised not to touch the controller and to come in the next morning for a controller exchange; however, the patient proceeded to exchange the controller to the back up controller, and the ventricular assist device (vad) did not restart.The patient was brought to the hospital by ambulance, and the vad restarted at some point in the ambulance.Upon arrival to the hospital, the patient was stable.It was also reported that one battery exhibited a power disconnect alarm.The primary controller was removed from service, the patient remained on the backup controller and the battery was replaced.Approximately ten days later the vad exhibited a vad stop alarm again and the vad did not restart while using the backup controller.The patient was sleeping while connected to the alternating current (ac) adapter and battery.The patient disconnected the ac adapter to go to the restroom and the alarms were heard.The patient contacted the vad coordinator while the vad stopped alarms were occurring.Eventually the vad restarted on the backup controller.It was noted that the patient went into the clinic for logfiles collection, and the backup controller was exchanged.It was also reported that five days after the clinic visit, the vad stopped again while using the controller exchanged for the back up one in the clinic and did not restart.The patient was rushed to the hospital in a declining state with unknown alarms sounding.An attempt to restart the vad using an ac adapter was made.It was then decided to perform an emergency vad exchange and the patient subsequently expired.
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.Concomitant medical products: dtma1qq icd implant date (b)(6) 2020 additional products: brand name: heartware ventricular assist system ¿ controller model#: 1420 / catalog#: 1420 / expiration date: 30-april-2022 / serial#: (b)(4).Udi#: (b)(4).Device available for evaluation: yes, return date: 08-aug-2022 device evaluated by mfr: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes mfg date: 19-april-2021 labeled for single use: no (b)(4).Brand name: controller model#: 1420 / catalog#: 1420 / expiration date: 30-june-2022 / serial#: (b)(4) udi#: (b)(4) device evaluated by mfr: no, device evaluation anticipated, but not yet begun mfg date: 01-june-2021 labeled for single use: no (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.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information: b5, h6 and additional codes.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.
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Event Description
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It was further reported that "the lvad started ringing" and the patient experienced chest pain and shortness of breath and it was reading to replace the controller.The power was plugged into the wall, the battery was charged and the vad "restarted multiple times without success".The patient became increasingly dyspneic with wheezing and was started on intravenous medications in preparation for surgery "necessitated by the failing lvad".It was indicated that the patient was "critically ill due to lvad dysfunction".During the procedure to remove the vad, the patient began hemorrhaging and efforts to control the bleeding were unsuccessful.The patient was removed from bypass support and subsequently passed away.
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Manufacturer Narrative
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Supplemental is being submitted for additional information.Additional products: (b)(6) ¿ controller 2.0 h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c0706 h6: fda conclusion code(s): d01 (b)(6) ¿ controller 2.0 h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c21, c19 h6: fda conclusion code(s): d10, d16, d15 (b)(6) ¿ controller 2.0 h3: yes h6: img code(s): (b)(6) h6: fda method code(s): b01, b15 h6: fda results code(s): c02 h6: fda conclusion code(s): d02 (b)(6) ¿ battery h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 product event summary: ventricular assist device (vad) (b)(6), one (1) controller (b)(6), and one (1) battery (b)(6), were not returned for evaluation.Two (2) controllers ((b)(6)) were returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of (b)(6) revealed that the controller passed visual inspection and functional testing.Failure analysis of (b)(6) revealed bent pins within power port two (2).The bent pins do not allow a power source to connect to the controller.Log file analysis revealed that (b)(6) was the patient¿s primary controller, initially in use during the reported event date.Analysis of the controller log files associated with (b)(6) revealed a vad disconnect alarm was logged on (b)(6) 2022 at 23:18:18 indicating a physical disconnection of the driveline from the controller, likely due to the reported controller exchange.A controller power up event with a successful pump start event was logged on (b)(6) 2022 at 23:38:06, likely due to troubleshooting during the reported controller exchange between (b)(6) to (b)(6).Additionally, multiple controller power up events without pump start events and vad disconnect alarms due to a physical disconnection of the driveline from the controller, were logged on (b)(6) 2022 since 23:20:50, likely to troubleshooting following an after the reported controller exchange.Log file analysis associated with (b)(6) revealed three (3) controller power up events logged on (b)(6)2022 at 22:24:02, 22:24:39, and 22:25:28, indicating that the controller was put into use following the reported controller exchange.Review of the alarm log file associated (b)(6) revealed one (1) power disconnect alarm, three (3) vad stopped alarms, and one (1) vad disconnect alarm were logged on (b)(6) 2022.The power disconnect alarm was logged at 22:25:34 involving (b)(6).During the power disconnect alarm, safety alert word (saw) values involving (b)(6) was recorded indicating an overcurrent alert.The event log recorded a high-power consumption during the attempted motor starts, which required more current from the batteries.(b)(6) was most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.It is likely that the overcurrent condition prevented (b)(6) from providing power, resulting in losses of power to the controller logged at 22:24:39, and 22:25:28.A vad stopped alarm was logged at 22:25:34, indicating a failure of the pump to restart after multiple attempts.T his was followed by three (3) additional controller power up events, two additional vad stopped alarms indicating a failure of the pump to restart after multiple attempts and a vad disconnect alarm indicating a physical disconnection of the driveline from the cont roller, logged between 22:25:50 and 22:44:16, likely due to troubleshooting on(b)(6) 2022.A successful pump start event was logged on (b)(6) 2022 at 22:44:26.Of note, based on the log files, the initial controller power up events and vad stopped alarms on (b)(6) were recorded while (b)(6) was still in use, indicating that there was likely an incorrect time setting on the backup controller.Log file analysis associated with (b)(6) then revealed two (2) controller power up events were logged on (b)(6) 2022 at 08:34:33 and 08:36:02.The data point prior to the first loss of power revealed that (b)(6) was connected to power port one (1) with 87% relative state of charge (rsoc) and a controller adapter was connected to power port two (2).No anomalies were observed leading up to the loss of power.The data point after the first loss of power revealed that (b)(6) was connected to power port 1 and there was no power source connected to power port two (2).After the loss of power at 08:34:33, safety alert word (saw) values were recorded on (b)(6), indicating an overcurrent alert.It is likely that the overcurrent condition prevented the battery from providi ng power, resulting in loss of power to the controller.The data point prior to the second loss of power revealed that (b)(6) was connected to power port one (1) and there was no power source connected to power port two (2).The data point after the second loss of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).Review of the alarm log file associated (b)(6) then revealed two (2) vad stopped alarms and one (1) vad disconnect alarm were logged on (b)(6)2022.A vad stopped alarm was logged 08:36:29, indicating a failure of the pump to restart after multiple attempts.This was followed by a vad disconnect alarm indicating a physical disconnection of the driveline from the controller, an additional vad stopped alarm indicating a failure of the pump to restart after multiple attempts, and an additional controller power up event, logged between 08:44:55 and 08:47:43, likely due to troubleshooting after a controller exchange attempt from (b)(6).Two (2) successful pump start events were logged on (b)(6) 2022 at 08:44:40 and at 08:47:59.Further review of the controller log files associated with (b)(6) revealed a controller power up event was logged on (b)(6)2022 at 14:32:33.The data point prior to the first loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two with 99% rsoc.The data point after the loss of power revealed that a controller adapter was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for 14 seconds.Based on the available information, the controller power up event likely occurred during a controller exchange attempt for (b)(6).Further review of the alarm log file associated with (b)(6) revealed two (2) vad stopped alarms and six (6) vad disconnect alarms were logged on (b)(6)2022.A vad stopped alarm was logged 14:33:10, indicating a failure of the pump to restart after multiple attempts.This was followed by five (5) vad disconnect alarms indicating a physical disconnection of the driveline from the controller, one (1) additional vad stopped alarm indicating a failure of the pump to restart after multiple attempts, and a four (4) additional controller power up events, logged between 14:36:46 and 15:07:04, likely due to troubleshooting.Log file analysis associated with (b)(6) revealed four (4) vad disconnect alarms and three (3) controller power up events were logged on (b)(6) 2022 between 09:41:03 and 09:45:29, likely due to troubleshooting during a controller exchange from (b)(6).A vad disconnect alarm was logged at 09:41:11 was likely due to the controller being powered on without the driveline connected.A second vad disconnect alarm at 09:41:52 was logged during a pump start attempt.This 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 physically connected to the controller.This was followed by two (2) additional control power up events without pump start events and two (2) additional vad disconnect alarms indicating a physical disconnection of the driveline from the controller, likely due to troubleshooting during a controller exchange from (b)(6).Of note, based on the log files, the controller power up events and vad disconnect alarms on (b)(6) were recorded while (b)(6) was still in use, indicating that there was likely an incorrect time setting on the backup controller.Review of the available log files associated with (b)(6) revealed two (2) vad disconnect alarms, five (5) vad stopped alarms, and four (4) controller power up events were logged on (b)(6) 2022 between 15:14:23 and 16:19:58, likely due to troubleshooting during a controller exchange from (b)(6).A vad disconnect alarm was logged at 15:14:30 was likely due to the controller being powered on without the driveline connected.A vad stopped alarm was logged at 15:15:08, indicating a failure of the pump to restart after multiple attempts.This was followed by an additional vad disconnect alarm indicating a physical disconnection of the driveline from the controller, three (3) additional control power up events and four (4) additional vad stopped alarms indicating a failure of the pump to restart after multiple attempts, logged between 15:42:55 and 16:18:58, likely due to troubleshooting.As a result, the reported events were confirmed.Based on an investigation conducted under capa pr00384004, the root cause of bent socket pins within power port connectors is attributed to misalignment during connection attempts between the metal receptacles on the controllers and the plastic connector plugs in the battery and/or adapter cables.The misalignment results in wear on the connector plugs that can lead to contact between the connector plug and socket pins from the controllers.The socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.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.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller loss of power during pump start due to battery discharge overcurrent condition.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(s) of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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.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.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation and a revision to the product event summary.Product event summary: the pump ((b)(6)), one (1) controller ((b)(6)), and one (1) battery ((b)(6)) were not returned for eva luation.Two (2) controllers ((b)(6)) were 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 (b)(6) revealed that the controller passed visual inspection and functional testing.Failure analysis of (b)(6) revealed bent pins within power port two (2).The bent pins do not allow a power source to connect to the controller.Log file analysis revealed that (b)(6) was the patient¿s primary controller, initially in use during the reported event date.Analysis of the controller log files associated with (b)(6) revealed a vad disconnect alarm was logged on 21-jul-2022 at 23:18:18 indicating a physical disconnection of the driveline from the controller, likely due to the reported controller exchange.An controller power up event with a successful pump start event was logged on 21/jul/2022 at 23:38:06, likely due to troubleshooting during the reported controller exchange between (b)(6).Additionally, multiple controller power up events without pump start events and vad disconnect alarms due to a physical disconnection of the driveline from the controller, were logged on 21-jul-2022 since 23:20:50, likely to troubleshooting following an after the reported controller exchange.Log file analysis associated with (b)(6) revealed three (3) controller power up events logged on 21-jul-2022 at 22:24:02, 22:24:39, and 22:25:28, indicating that the controller was put into use following the reported controller exchange.Review of the alarm log file associated con417144 revealed one (1) power disconnect alarm, three (3) vad stopped alarms, and one (1) vad disconnect alarm were logged on 21-jul-2022.The power disconnect alarm was logged at 22:25:34 involving (b)(6).During the power disconnect alarm, safety alert word (saw) values involving (b)(6) was recorded indicating an overcurrent alert.The event log recorded a high-power consumption during the attempted motor starts, which required more current from the batteries.(b)(6) was most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.It is likely that the overcurrent condition prevented (b)(6) from providing power, resulting in losses of power to the controller logged at 22:24:39, and 22:25:28.A vad stopped alarm was logged at 22:25:34, indicating a failure of the pump to restart after multiple attempts.T his was followed by three (3) additional controller power up events, two additional vad stopped alarms indicating a failure of the pump to restart after multiple attempts and a vad disconnect alarm indicating a physical disconnection of the driveline from the cont roller, logged between 22:25:50 and 22:44:16, likely due to troubleshooting on 07-21-2022.A successful pump start event was logged on 21-jul-2022 at 22:44:26.Of note, based on the log files, the initial controller power up events and vad stopped alarms on (b)(6) were recorded while (b)(6) was still in use, indicating that there was likely an incorrect time setting on the backup controller.Log file analysis associated with (b)(6) then revealed two (2) controller power up events were logged on 31-jul-2022 at 08:34:33 and 08:36:02.The data point prior to the first loss of power revealed that (b)(6) was connected to power port one (1) with 87% relative state of charge (rsoc) and a controller adapter was connected to power port two (2).No anomalies were observed leading up to the loss of power.The data point after the first loss of power revealed that (b)(6) was connected to power port 1 and there was no power source connected to power port two (2).After the loss of power at 08:34:33, safety alert word (saw) values were recorded on (b)(6), indicating an overcurrent alert.It is likely that the overcurrent condition prevented the battery from providi ng power, resulting in loss of power to the controller.The data point prior to the second loss of power revealed that (b)(6) was connected to power port one (1) and there was no power source connected to power port two (2).The data point after the second loss of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).Review of the alarm log file associated (b)(6) then revealed two (2) vad stopped alarms and one (1) vad disconnect alarm were logged on 31-jul-2022.A vad stopped alarm was logged 08:36:29, indicating a failure of the pump to restart after multiple attempts.This was followed by a vad disconnect alarm indicating a physical disconnection of the driveline from the controller, an additional vad stopped alarm indicating a failure of the pump to restart after multiple attempts, and an additional controller power up event, logged between 08:44:55 and 08:47:43, likely due to troubleshooting after a controller exchange attempt from (b)(6) to (b)(6).Two (2) successful pump start events were logged on 31-jul-2022 at 08:44:40 and at 08:47:59.Further review of the controller log files associated with (b)(6) revealed a controller power up event was logged on 05-aug-2022 at 14:32:33.The data point prior to the first loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two with 99% rsoc.The data point after the loss of power revealed that a controller adapter was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for 14 seconds.Based on the available information, the controller power up event likely occurred during a controller exchange attempt for (b)(6).Further review of the alarm log file associated with (b)(6) revealed two (2) vad stopped alarms and six (6) vad disconnect alarms were logged on 05-aug-2022.A vad stopped alarm was logged 14:33:10, indicating a failure of the pump to restart after multiple attempts.This was followed by five (5) vad disconnect alarms indicating a physical disconnection of the driveline from the controller, one (1) additional vad stopped alarm indicating a failure of the pump to restart after multiple attempts, and an four (4) additional controller power up events, logged between 14:36:46 and 15:07:04, likely due to troubleshooting.Log file analysis associated with (b)(6) revealed four (4) vad disconnect alarms and three (3) controller power up events were logged on 31-jul-2022 between 09:41:03 and 09:45:29, likely due to troubleshooting during a controller exchange from (b)(6) to (b)(6).A vad disconnect alarm was logged at 09:41:11 was likely due to the controller being powered on without the driveline connected.A second vad disconnect alarm at 09:41:52 was logged during a pump start attempt.This 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 physically connected to the controller.This was followed by two (2) additional control power up events without pump start events and two (2) additional vad disconnect alarms indicating a physical disconnection of the driveline from the controller, likely due to troubleshooting during a controller exchange from (b)(6) to (b)(6).Of note, based on the log files, the controller power up events and vad disconnect alarms on (b)(6) were recorded while (b)(6) was still in use, indicating that there was likely an incorrect time setting on the backup controller.Review of the available log files associated with (b)(6) revealed two (2) vad disconnect alarms, five (5) vad stopped alarms, and four (4) controller power up events were logged on 05-aug-2022 between 15:14:23 and 16:19:58, likely due to troubleshooting during a controller exchange from (b)(6) to (b)(6).A vad disconnect alarm was logged at 15:14:30 was likely due to the controller being powered on without the driveline connected.A vad stopped alarm was logged at 15:15:08, indicating a failure of the pump to restart after multiple attempts.This was followed by an additional vad disconnect alarm indicating a physical disconnection of the driveline from the controller, three (3) additional control power up events and four (4) additional vad stopped alarms indicating a failure of the pump to restart after multiple attempts, logged between 15:42:55 and 16:18:58, likely due to troubleshooting.As a result, the reported events were confirmed.Based on an investigation conducted under capa pr00384004, the root cause of bent socket pins within power port connectors is attributed to misalignment during connection attempts between the metal receptacles on the controllers and the plastic connector plugs in the battery and/or adapter cables.The misalignment results in wear on the connector plugs that can lead to contact between the connector plug and socket pins from the controllers.The socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.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.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller loss of power during pump start due to battery discharge overcurrent condition.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 disconnections of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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.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.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information: b5, b7, h6 and additional codes.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.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.
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Event Description
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It was further reported that upon return from the operating room after ventricular assist device (vad) exchange to the intensive care unit, the hemorrhaging continued and the patient was on cardiopulmonary bypass and received multiple shocks for ventricular tachycardia (vt) and was given advanced life support medications and massive transfusions and was subsequently removed from bypass and passed away.
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Manufacturer Narrative
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A supplemental is being submitted for additional information.Product event summary: ventricular assist device (b)(6), one (1) controller (b)(6), and one (1) battery (b)(6) were not returned for evaluation.Two (2) controllers (b)(6) were returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of (b)(6) revealed that the controller passed visual inspection and functional testing.Failure analysis of (b)(6) revealed bent pins within power port two (2).The bent pins do not allow a power source to connect to the controller.Log file analysis revealed that (b)(6) was the patient¿s primary controller, initially in use during the reported event date.Analysis of the controller log files associated with (b)(6) revealed a vad disconnect alarm was logged on (b)(6)2022 at 23:18:18 indicating a physical disconnection of the driveline from the controller, likely due to the reported controller exchange.A controller power up event with a successful pump start event was logged on (b)(6) 2022 at 23:38:06, likely due to troubleshooting during the reported controller exchange between (b)(6) to (b)(6).Additionally, multiple controller power up events without pump start events and vad disconnect alarms due to a physical disconnection of the driveline from the controller, were logged on (b)(6) 2022 since 23:20:50, likely to troubleshooting following an after the reported controller exchange.Log file analysis associated with (b)(6) revealed three (3) controller power up events logged on (b)(6) 2022 at 22:24:02, 22:24:39, and 22:25:28, indicating that the controller was put into use following the reported controller exchange.Review of the alarm log file associated (b)(6) revealed one (1) power disconnect alarm, three (3) vad stopped alarms, and one (1) vad disconnect alarm were logged on (b)(6) 2022.The power disconnect alarm was logged at 22:25:34 involving (b)(6).During the power disconnect alarm, safety alert word (saw) values involving (b)(6) was recorded indicating an overcurrent alert.The event log recorded a high-power consumption during the attempted motor starts, which required more current from the batteries.(b)(6) was most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.It is likely that the overcurrent condition prevented (b)(6) from providing power, resulting in losses of power to the controller logged at 22:24:39, and 22:25:28.A vad stopped alarm was logged at 22:25:34, indicating a failure of the pump to restart after multiple attempts.This was followed by three (3) additional controller power up events, two additional vad stopped alarms indicating a failure of the pump to restart after multiple attempts and a vad disconnect alarm indicating a physical disconnection of the driveline from the cont roller, logged between 22:25:50 and 22:44:16, likely due to troubleshooting on (b)(6) 2022.A successful pump start event was logged on (b)(6) 2022 at 22:44:26.Of note, based on the log files, the initial controller power up events and vad stopped alarms on (b)(6) were recorded while (b)(6) was still in use, indicating that there was likely an incorrect time setting on the backup controller.Log file analysis associated with (b)(6) then revealed two (2) controller power up events were logged on (b)(6) 2022 at 08:34:33 and 08:36:02.The data point prior to the first loss of power revealed that (b)(6) was connected to power port one (1) with 87% relative state of charge (rsoc) and a controller adapter was connected to power port two (2).No anomalies were observed leading up to the loss of power.The data point after the first loss of power revealed that (b)(6) was connected to power port one (1) and there was no power source connected to power port two (2).After the loss of power at 08:34:33, safety alert word (saw) values were recorded on (b)(6), indicating an overcurrent alert.It is likely that the overcurrent condition prevented the battery from providing power, resulting in loss of power to the controller.The data point prior to the second loss of power revealed that (b)(6) was connected to power port one (1) and there was no power source connected to power port two (2).The data point after the second loss of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).Review of the alarm log file associated (b)(6) then revealed two (2) vad stopped alarms and one (1) vad disconnect alarm were logged on (b)(6) 2022.A vad stopped alarm was logged 08:36:29, indicating a failure of the pump to restart after multiple attempts.This was followed by a vad disconnect alarm indicating a physical disconnection of the driveline from the controller, an additional vad stopped alarm indicating a failure of the pump to restart after multiple attempts, and an additional controller power up event, logged between 08:44:55 and 08:47:43, likely due to troubleshooting after a controller exchange attempt from (b)(6) to (b)(6).Two (2) successful pump start events were logged on (b)(6)2022 at 08:44:40 and at 08:47:59.Further review of the controller log files associated with (b)(6) revealed a controller power up event was logged on (b)(6) 2022 at 14:32:33.The data point prior to the first loss of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two with 99% rsoc.The data point after the loss of power revealed that a controller adapter was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for 14 seconds.Based on the available information, the controller power up event likely occurred during a controller exchange attempt for (b)(6).Further review of the alarm log file associated with (b)(6) revealed two (2) vad stopped alarms and six (6) vad disconnect alarms were logged on (b)(6) 2022.A vad stopped alarm was logged 14:33:10, indicating a failure of the pump to restart after multiple attempts.This was followed by five (5) vad disconnect alarms indicating a physical disconnection of the driveline from the controller, one (1) additional vad stopped alarm indicating a failure of the pump to restart after multiple attempts, and a four (4) additional controller power up events, logged between 14:36:46 and 15:07:04, likely due to troubleshooting.Log file analysis associated with (b)(6) revealed four (4) vad disconnect alarms and three (3) controller power up events were logged on (b)(6) 2022 between 09:41:03 and 09:45:29, likely due to troubleshooting during a controller exchange from (b)(6) to (b)(6).A vad disconnect alarm was logged at 09:41:11 was likely due to the controller being powered on without the driveline connected.A second vad disconnect alarm at 09:41:52 was logged during a pump start attempt.This 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 physically connected to the controller.This was followed by two (2) additional control power up events without pump start events and two (2) additional vad disconnect alarms indicating a physical disconnection of the driveline from the controller, likely due to troubleshooting during a controller exchange from (b)(6).Of note, based on the log files, the controller power up events and vad disconnect alarms on (b)(6) were recorded while (b)(6) was still in use, indicating that there was likely an incorrect time setting on the backup controller.Review of the available log files associated with (b)(6) revealed two (2) vad disconnect alarms, five (5) vad stopped alarms, and four (4) controller power up events were logged on (b)(6) 2022 between 15:14:23 and 16:19:58, likely due to troubleshooting during a controller exchange from (b)(6) to (b)(6).A vad disconnect alarm was logged at 15:14:30 was likely due to the controller being powered on without the driveline connected.A vad stopped alarm was logged at 15:15:08, indicating a failure of the pump to restart after multiple attempts.This was followed by an additional vad disconnect alarm indicating a physical disconnection of the driveline from the controller, three (3) additional control power up events and four (4) additional vad stopped alarms indicating a failure of the pump to restart after multiple attempts, logged between 15:42:55 and 16:18:58, likely due to troubleshooting.As a result, the reported events were confirmed.Based on an investigation conducted under capa pr00384004, the root cause of bent socket pins within power port connectors is attributed to misalignment during connection attempts between the metal receptacles on the controllers and the plastic connector plugs in the battery and/or adapter cables.The misalignment results in wear on the connector plugs that can lead to contact between the connector plug and socket pins from the controllers.The socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.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.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller loss of power during pump start due to battery discharge overcurrent condition.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(s) of the driveline from the controller.Capa pr00550440 is investigating controller losses of synchronization of commutation.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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.
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