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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); Pumping Problem (3016)
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| Patient Problems
Hemorrhage/Bleeding (1888); Heart Failure (2206); Thrombosis/Thrombus (4440)
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| Event Date 06/10/2020 |
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Event Type
Injury
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Manufacturer Narrative
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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.Additional products: brand name: heartware ventricular assist system ¿ outflow graft, medical device: model #: 1125 / catalog #: 1125 / expiration date: 31-jul-2023 / serial or lot#: (b)(4), udi #:(b)(4).Device available for evaluation? yes, return date: 15-jun-2020.Device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Device mfg date: 01-jul-2018.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-dec-2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation? no.Device mfg date: 05-dec-2018.Labeled for single use? no.(b)(4).Brand name: heartware ventricular assist system ¿ battery, medical device: model #: 1650de / catalog #: 1650de / expiration date: 31-jan-2020 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation? no.Device mfg date: 17-jan-2019.Labeled for single use? no.(b)(4).Brand name: heartware ventricular assist system ¿ battery, medical device: model #: 1650de / catalog #: 1650de / expiration date: 30-nov-2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation?: no.Device mfg date: 07-nov-2018.Labeled for single use? no.(b)(4).Brand name: heartware ventricular assist system ¿ battery, medical device: model #: 1650de / catalog #: 1650de / expiration date: 30-nov-2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation? no.Device mfg date: 07-nov-2018.Labeled for single use? no.(b)(4).Investigation of this event is pending and a supplemental report will be sent upon its completion.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 disconnected both batteries.When the batteries were plugged back in, the ventricular assist device (vad) stopped and an alarm occurred.A controller exchange was attempted but was unsuccessful and the vad did not start.Prior to stopping, the vad exhibited high power and low flows.It was also reported that the controller had an unexpected loss of power.It was also reported that one battery exhibited a critical battery alarm due to a communication error and had a power disconnect.It was also reported two additional batteries exhibited power disconnects.The patient was admitted to the intensive care unit (icu) with worsening heart failure and was placed on blood pressure medication and inotropes.The vad was exchanged.The controller and batteries remain in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted to add details and devices.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-dec-2020 / serial or lot#:(b)(4)., udi #: (b)(4).D10: no h4: mfg date: 20-dec-2019 h5: no h6: patient code(s): c50675 h6: device code(s): c63025, c63007, c63223 h6: fda results code(s): 3233 h6: fda conclusion code(s): 11 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-dec-2019 / serial or lot#: (b)(4).Udi #: (b)(4).D10: no h4: mfg date: 17-dec-2018 h5: no h6: patient code(s): c50675 h6: device code(s): c63025, c63007, c63223 h6: fda results code(s): 3233 h6: fda conclusion code(s): 11 d1: heartware ventricular assist system ¿ controller ac adapter d4: model #: 1403us / catalog #: 1403us / expiration date: 31-mar-2022 / serial or lot#: (b)(4).Udi #: (b)(4).D10: no h4: mfg date: unk h5: no h6: patient code(s): c50675 h6: device code(s): c63025 h6: fda results code(s): 3233 h6: fda conclusion code(s): 11 d1: heartware ventricular assist system ¿ controller ac adapter d4: model #: 1403us / catalog #: 1403us / expiration date: unk / serial or lot#: (b)(4).Udi #: (b)(4).D10: no h4: mfg date: unk h5: no h6: patient code(s): c50675 h6: device code(s): c63025 h6: fda results code(s): 3233 h6: fda conclusion code(s): 11 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-jan-2021 / serial or lot#: (b)(4).Udi #: (b)(4).D10: no h4: mfg date: 07-jan-2020 h5: no h6: patient code(s): (b)(4).H6: device code(s): c63030 h6: fda results code(s): 3233 h6: fda conclusion code(s): 11 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: unk / serial or lot#: (b)(4).Udi #: (b)(4).D10: no h4: mfg date: unk h5: no h6: patient code(s): c50675 h6: device code(s): c63030 h6: fda results code(s): 3233 h6: fda conclusion code(s): 11 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.
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Event Description
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It was further reported that two controllers exhibited double disconnects of power sources, loss of power, controller faults and vad disconnects with motor stators not restarting.The vad stops were suspected to have been caused by the power sources.All of the patient's controllers and power sources were exchanged.
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Manufacturer Narrative
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A supplemental report is being submitted for additional event details.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.
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Event Description
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It was further reported that there was patent flow through the outflow graft and inflow cannula during an echocardiogram.When the controllers were exchanged, the watts "shot way up, " no flow was exhibited and a "vad stopped.Connect dl" alarm occurred.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.Product event summary: one (1) pump and associated outflow graft, three (3) controllers, five (5) batteries, and two (2) controller ac adapters were 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 pump revealed that the device passed visual examination, functional testing, and dimensional verification.Internal pathological report revealed no evidence of thrombus within the device.Failure analysis of the returned outflow graft revealed that the device passed visual examination.Failure analysis of the returned controllers, batteries, and controller ac adapters revealed that the devices passed visual inspection and functional testing.Review of the controller log files associated with the first controller revealed a controller power up event on (b)(6) 2020 at 17:05:54.The data point prior to the loss of power revealed that a power adapter was connected to power port one (1) and the first battery was connected to power port two (2) with 95% relative state of charge (rsoc).The data point recorded after the loss of power revealed that the second battery was connected to power port one (1) and the first battery was connected to power port two (2).The controller was without power for 17 seconds.A vad stopped alarm was logged at 17:06:21 due to a failure of the pump to restart after several attempts.This was followed by two (2) vad disconnect alarms, indicating a physical disconnection of the driveline from the controller, and an additional controller power up event at 17:17:14, likely due to troubleshooting.Review of the controller log files associated with the second controller revealed a controller power up event on (b)(6)2020 at 17:14:54.Review of the event log file revealed that, prior to the first power up event, the controller last had power on (b)(6) 2019, indicating that the power up event occurred during a controller exchange.A vad disconnect alarm was logged at 17:14:59 due to the controller powering up without a driveline connected.A vad stopped alarm was then logged at 17:15:33 due to a failure of the pump to restart after several attempts.A successful motor start event was then logged at 17:17:42 on the first controller after a controller exchange and the controller remained in use.Additionally, review of the controller log files associated with the first controller revealed a controller power up event on (b)(6) 2020 at 08:38:38.The data point prior to the loss of power revealed that the third battery was connected to power port one (1) with 98% rsoc and the first battery was connected to power port two (2) with 88% rsoc.The data point recorded after the loss of power revealed that the second battery was connected to power port one (1) and no power source was connected to power port two (2).The controller was without power 10 seconds.A vad disconnect alarm was then logged at 08:38:50 followed by two more controller power up events, which were likely due to troubleshooting.An analysis of the alarm file revealed that 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.A vad stopped alarm was logged at 08:41:15 due to a failure of the pump to restart after several attempts.This was followed by additional controller power up events, vad stopped alarms and vad disconnect alarms, likely due to troubleshooting.Log file analysis revealed that a controller exchange was performed to the third controller and a vad stopped alarm was logged on (b)(6) 2020 at 08:51:43 indicating a failure of the pump to restart after several attempts.This was also followed by additional controller power up events, vad stopped alarms, and vad disconnect alarms likely due to troubleshooting.Of note, review of the log files revealed high power consumption recorded during the failure to restart attempts.Furthermore, several power disconnect alarms were observed involving the first, second and third batteries on the first and third controllers.During the power disconnect alarms, a safety alert word (saw) value was recorded indicating an overcurrent alert.At the time of the power disconnect alarms with an overcurrent alert, the alarm log recorded high power consumption, indicating a higher current consumption from the battery.The batteries were most likely physically disconnected, causing the controller to log these events as a power disconnect alarm.Log file analysis also revealed 9 critical battery alarms involving the third battery starting at 11:58:18 on (b)(6) 2020 due to the battery depleting below 10% relative state of charge (rsoc).No low flow alarms, communication errors, or controller fault alarms were observed during t he analyzed period.As a result, the reported controller loss of power event, vad stopped alarms, vad disconnect alarms, power disconnect alarms, high power consumption and critical battery alarms were confirmed; however, the reported low flow, communication errors, and controller fault alarms could not be confirmed.Based on the available information, a possible root cause of the vad disconnect alarm associated with the first controller on (b)(6) 2020 at 08:38:50 can be attributed to a loss of synchronization of commutation, leading to a false vad disconnect alarm.A possible root cause of the on (b)(6) 2020 loss of power associated with the first controller can be attributed to a disconnection of both power sources and / or to an intermittent disconnection on both power sources.The most likely root cause of the on (b)(6) 2020 loss of power event associated with the first controller can be attributed to the reported disconnection of both power sources from the controller, as described in the event details.A possible root cause of the reported power disconnect alarms may be attributed, but not limited, to a physical disconnection of the power source.The most likely root cause of the additional vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the critical battery alarms can be attributed to the patient allowing the batteries to deplete below 10%.Based on historical review of similar events, the likely contributing cause for failures to restart was the inability of the pump-start algorithm to provide sufficient torque to overcome abnormally high mechanical resistance caused by unknown conditions that existed prior to the failed restart attempt.D4: serial or lot#: (b)(6) / h3: yes / h6: fda method code(s): 10 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 67 / d4: serial or lot#: (b)(6) / udi#: (b)(4) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 120, 213 h6: fda conclusion code(s): 19, 22, 4307, 4310, 4315 / d4: serial or lot#: (b)(6) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 19, 22 / d4: serial or lot#: (b)(6) / udi#: (b)(4) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 67 / d4: serial or lot#: (b)(6) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 19, 22 / d4: serial or lot#: (b)(6) / udi#: (b)(4) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 4310 / d4: serial or lot#:(b)(6) / udi#: (b)(4) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 4310 / d4: serial or lot#: (b)(6) / udi#: (b)(4) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 67 / d4: serial or lot#: (b)(6) / udi#: (b)(4) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 67 / d4: serial or lot#: (b)(6) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 67 / d4: serial or lot#: (b)(6) / d10: yes, return date: 07-jul-2020 / h3: yes dev rtn to mfr? yes / h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 22, 67.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.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Additional information was received regarding the recall number.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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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 vad had thrombus and the patient also experienced an unspecified bleed.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation and an update to investigation summary.Revised product event summary: one (1) pump (b)(6) and associated outflow graft (lot.No.17409364-1276), three (3) controllers ( (b)(6), five (5) batteries (b)(6), and two (2) controller ac adapters (b)(6) were 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 controllers (b)(6), batteries (b)(6), and controller ac adapters (b)(6) revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned outflow graft revealed that the device passed visual examination.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Internal pathological report revealed no evidence of thrombus within the device.Dimensional verification revealed that the rear housing disc curvature and front housing disc curvature were found to be deviating from release specifications.Capa: pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface, this increase in friction was investigated during the capa: pr00502194 investigation.Review of the controller log files associated with (b)(6) revealed a controller power up event on 24/may/2020 at 17:05:54.The data point prior to the loss of power revealed that a power adapter was connected to power port one (1) and (b)(6) was connected to power port two (2) with 95% relative state of charge (rsoc).The data point recorded after the loss of power revealed that (b)(6) was connected to power port one (1) and (b)(6) was connected to power port two (2).The controller was without power for 17 seconds.A vad stopped alarm was logged at 17:06:21 due to a failure of the pump to restart after several attempts.This was followed by two (2) vad disconnect alarms, indicating a physical disconnection of the driveline from the controller, and an additional controller power up event at 17:17:14, likely due to troubleshooting.Review of the controller log files associated with (b)(6) revealed a controller power up event on 24/may/2020 at 17:14:54.Review of the event log file revealed that, prior to the first power up event, the controller last had power on (b)(6)2019, indicating that the power up event occurred during a controller exchange.A vad disconnect alarm was logged at 17:14:59 due to the controller powering up without a driveline connected.A vad stopped alarm was then logged at 17:15:33 due to a failure of the pump to restart after several attempts.A successful motor start event was then logged at 17:17:42 on (b)(6) after a controller exchange and the controller remained in use.Additionally, review of the controller log files associated with (b)(6) revealed a controller power up event on 10/jun/2020 at 08:38:38.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 98% rsoc and (b)(6) was connected to power port two (2) with 88% rsoc.The data point recorded after the loss of power revealed that (b)(6) was connected to power port one (1) and no power source was connected to power port two (2).The controller was without power 10 seconds.A vad disconnect alarm was then logged at 08:38:50 followed by two more controller power up events, which were likely due to troubleshooting.An analysis of the alarm file revealed that 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.A vad stopped alarm was logged at 08:41:15 due to a failure of the pump to restart after several attempts.This was followed by additional controller power up events, vad stopped alarms and vad disconnect alarms, likely due to troubleshooting.Log file analysis revealed that a controller exchange was performed to (b)(6) and a vad stopped alarm was logged on 10/jun/2020 at 08:51:43 indicating a failure of the pump to restart after several attempts.This was also followed by additional controller power up events, vad stopped alarms, and vad disconnect alarms likely due to troubleshooting.Of note, review of the log files revealed high power consumption recorded during the failure to restart attempts.Furthermore, several power disconnect alarms were observed involving (b)(6)on controllers (b)(6).During the power disconnect alarms, a safety alert word (saw) value was recorded indicating an overcurrent alert.At the time of the power disconnect alarms with an overcurrent alert, the alarm log recorded high power consumption, indicating a higher current consumption from the battery.The batteries were most likely physically disconnected, causing the controller to log these events as a power disconnect alarm.Log file analysis also revealed 9 critical battery alarms involving (b)(6) starting at 11:58:18 on (b)(6) 2020 due to the battery depleting below 10% relative state of charge (rsoc).No low flow alarms, communication errors, or controller fault alarms were observed during the analyzed period.As a result, the reported controller loss of power event, vad stopped alarms, vad disconnect alarms, power disconnect alarms, high power consumption and critical battery alarms were confirmed; however, the reported low flow, communication errors, and controller fault alarms could not be confirmed.Based on the available information, a possible root cause of the vad disconnect alarm associated with (b)(6) on (b)(6) 2020 at 08:38:50 can be attributed to a loss of synchronization of commutation, leading to a false vad disconnect alarm.Capa: pr00550440 is investigating controller losses of synchronization of commutation.A possible root cause of the on (b)(6) 2020 loss of power associated with (b)(6) can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on both power sources.The most likely root cause of the on (b)(6) 2020 loss of power event associated with (b)(6) can be attributed to the reported disconnection of both power sources from the controller, as described in the event details.Capa: pr00551638 is investigating controller losses of power.A possible root cause of the reported power disconnect alarms may be attributed, but not limited, to a physical disconnection of the power source.The most likely root cause of the additional vad disconnect alarms can be attributed to a physical disconnection of the driveline from the controller.The most likely root cause of the critical battery alarms can be attributed to the patient allowing the batteries to deplete below 10%.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) is part of fca cvg-21-q3-21.Capa: pr00502194 is investigating pump failures to restart.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, device thrombus, bleeding, and worsening heart failure are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, the patient did not have a history of similar adverse events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: d4: lot#: 17409364-1276, h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d12, d14, d4: serial#: (b)(6), h3: yes, h6: fda method code(s): b01, b15 h6: fda results code(s): c02, c19, c23 h6: fda conclusion code(s): d02, d10, d11, d12,d15, d4: serial#: (b)(6), h6: fda method code(s): b01, b15 h6: fda results code(s): c23 h6: fda conclusion code(s): d11, d12, d4: serial#: (b)(6), h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d12, d14, d4: serial #: (b)(6), h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d12,d14, d4: serial#: (b)(6), h3:yes, h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10, d12, d4: serial#: (b)(6), h3: yes, h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10, d12, d4: serial#: (b)(6), h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d12, d14, d4: serial#: (b)(6), h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d12, d14, d4: serial#: (b)(6), h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d12, d14, d4: serial#: (b)(6), h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d12, d14.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.
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