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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503)
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| Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 06/19/2021 |
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Event Type
Death
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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.Additional products: brand name: heartware ventricular assist system controller 2.0, medical device: model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2020 / serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by manufacturer.No, device evaluation anticipated, but not yet begun.Device mfg date: 22-jan-2019.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system controller 2.0, medical device: model #: 1420 / catalog #: 1420 / expiration date: 31-may-2020 / serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun.Device mfg date: 28-may-2019.Labeled for single use: no.(b)(4).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 reported that the patient was feeling unwell and went to go rest.As the patient was going to lay down a high priority ventricular assist device (vad) stop alarm was heard by their caregiver and upon observing patient they were reported to have a "glazed" look.The controller was exchanged and the patient collapsed and was unconscious.The controller was again exchanged and at that exchange the vad seemed to restart but promptly stopped again.The patient was transported to the hospital and pronounced deceased.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) and two controllers (b)(6) were not returned for evaluation.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use leading up to the reported event.Review of (b)(6)¿s log files revealed two (2) controller power up events on (b)(6) 2021 at 19:42:35 and at 19:42:48.The data point prior to the losses of power revealed that (b)(6) was connected to power port one (1) with 24% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 61% rsoc.The data point recorded after the losses of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were recorded leading up to the initial controller power up event.The controller was without power for 12 seconds and a maximum of 25 seconds, respectively.The controller power up events were not accompanied by a successful motor start event; a vad stopped alarm was logged at 19:43 :17, indicating that the pump failed to restart after multiple attempts.An additional controller power up event was logged at 19:43:40, followed by an additional vad stopped alarm due to the pump failing to restart at 19:43:58.A vad disconnect alarm was then logged at 19:45:54, indicating a physical disconnection of the driveline from the controller.Nine (9) additional controller power up events were logged on (b)(6) between 19:47:15 and 19:49:21, likely during troubleshooting, followed by a vad disconnect alarm at 19:49:31, indicating that the controller was powered on without the driveline attached.The vad disconnect alarm cleared, indicating that the driveline was connected to the controller, at 19:50:32.Another vad disconnect alarm was recorded at 19:50:47.An analysis of the alarm file revealed that the 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.Five (5) additional controller power up events, three (3) additional vad stopped alarms due to the failure of the pump to restart and two (2) additional vad disconnect alarms were logged between 19:51:11 and 20:17:58.Review of the log files associated with (b)(6) revealed a controller power up event on (b)(6) 2021 at 19:05:32; prior to the power up event, the controller last had power on (b)(6) 2021, indicating that the controller was put into use following the reported controller exchange.A vad disconnect alarm was logged at 19:05:37, indicating that the controller was powered on without the driveline attached.Two (2) additional controller power up events and two (2) associated vad disconnect alarms were logged between 19:09:30 and 19:11:01.Three (3) more controller power up events were recorded between 19:22:45 and 19:23:30, followed by a vad stopped alarm at 19:23:44, indicating that the pump failed to restart after multiple attempts.Thirty (30) additional controller power up events were logged between 19:24:32 and 19:32:54, likely during troubleshooting; two (2) additional vad stopped alarms due to failures of the pump to restart were also logged at 19:27:55 and 19:33:08.Of note, based on the log files, the controller power up events and vad stopped alarms recorded on con406063 were recorded at a time during which (b)(6) was still in use, indicating that there was likely an incorrect time setting on one of the controllers.As a result, the reported vad stop alarm event was confirmed.There was no evidence that the pump was able to restart following the initial loss of power; as a result, the reported "vad seemed to restart" event was not confirmed.(b)(6) is part of fca cvg-21-q3-21.A possible root cause of the original 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.Possible causes of the observed vad disconnect alarms can be attributed to a loss of synchronization of commutation, leading to a false vad disconnect alarm, and/or physical disconnections of the driveline from the controller, likely during troubleshooting.The most likely root cause of the vad stopped alarms can be attributed to failures of the pump to restart after multiple attempts.Capa pr00502194 is investigating pump failures to restart.Additional products: d1: controller d4: (b)(6) h3: yes h6: img code(s): g0200701, h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d1: controller d4: (b)(6) h3: yes h5: no, yes, if pump> h6: img code(s): g0200701, h6: fda method code(s): b15, b17 h6: fda results code(s): c02, c19 h6: fda conclusion code(s): d02, d10, d15, 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 is being submitted for additional information.Product event summary: ventricular assist device (vad) (b)(6) was 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 with both power ports.The damage did not allow a power source to connect to the controller.Internal inspection did not reveal any anomalies.Supplemental testing was performed and both power source connectors were replaced; after the damaged components were replaced, the controller functioned as intended.This is an additional finding not related to the reported event.Based on an investigation conducted under capa pr00384004, the root cause of the observed bent socket pins within power port connectors is attributed to misalignment during connection attempts between the metal receptible on the controller 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 controller.The socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use leading up to the reported event.Review of (b)(6)¿s log files revealed two (2) controller power up events on (b)(6) 2021 at 19:42:35 and at 19:42:48.The data point prior to the losses of power revealed that (b)(6) was connected to power port one (1) with (b)(4) relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with (b)(4) rsoc.The data point recorded after the losses of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were recorded leading up to the initial controller power up event.The controller was without power for 12 seconds and a maximum of 25 seconds, respectively.The controller power up events were not accompanied by a successful motor start event; a vad stopped alarm was logged at 19:43:17, indicating that the pump failed to restart after multiple attempts.An additional controller power up event was logged at 19:43:40, followed by an additional vad stopped alarm due to the pump failing to restart at 19:43:58.A vad disconnect alarm was then logged at 19:45:54, indicating a physical disconnection of the driveline from the controller.Nine (9) additional controller power up events were logged on (b)(6) between 19:47:15 and 19:49:21, likely during troubleshooting, followed by a vad disconnect alarm at 19:49:31, indicating that the controller was powered on without the driveline attached.The vad disconnect alarm cleared, indicating that the driveline was connected to the controller, at 19:50:32.Another vad disconnect alarm was recorded at 19:50:47.An analysis of the alarm file revealed that the 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.Five (5) additional controller power up events, three (3) additional vad stopped alarms due to the failure of the pump to restart and two (2) additional vad disconnect alarms were logged between 19:51:11 and 20:17:58.Review of the log files associated with (b)(6) revealed a controller power up event on (b)(6) 2021 at 19:05:32; prior to the power up event, the controller last had power on (b)(6) 2021, indicating that the controller was put into use following the reported controller exchange.A vad disconnect alarm was logged at 19:05:37, indicating that the controller was powered on without the driveline attached.Two (2) additional controller power up events and two (2) associated vad disconnect alarms were logged between 19:09:30 and 19:11:01.Three (3) more controller power up events were recorded between 19:22:45 and 19:23:30, followed by a vad stopped alarm at 19:23:44, indicating that the pump failed to restart after multiple attempts.Additionally, controller power up events were recorded on (b)(6) 2021 between 19:24:32 and 19:32:38 during attempted motor starts; the data points logged in the controller's internal logs prior to the losses of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two (2).Prior to the loss of powers, safety alert word (saw) value were recorded on the battery, indicating overcurrent alerts.The event log file recorded a high-power consumption during the attempted motor start, which required more current from the battery.It is likely overcurrent condition prevented the battery from providing power, resulting in a losses of power to the controller.Two (2) additional controller power up events were logged at 19:27:55 and 19:32:54, likely during troubleshooting; two (2) additional vad stopped alarms due to failures of the pump to restart were also logged at 19:27:55 and 19:33:08.Of note, based on the log files, the controller power up events and vad stopped alarms recorded on (b)(6) were recorded at a time during which (b)(6) was still in use, indicating that there was likely an incorrect time setting on one of the controllers.As a result, the reported vad stop alarm event was confirmed.There was no evidence that the pump was able to restart following the initial loss of power; as a result, the reported "vad seemed to restart" event was not confirmed.A possible root cause of the original 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.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller losses of power due to battery discharge overcurrent conditions during pump start attempts.Possible causes of the observed vad disconnect alarms can be attributed to a loss of synchronization of commutation, leading to a false vad disconnect alarm, and/or physical disconnections of the driveline from the controller, likely during troubleshooting.Capa pr00550440 is investigating controller losses of synchronization of commutation.The most likely root cause of the vad stopped alarms can be attributed to failures of the pump to restart after multiple attempts.(b)(6) is part of fca cvg-21-q3-21.Capa pr00502194 is investigating pump failures to restart.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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