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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Device Alarm System (1012); Failure to Pump (1502); Pumping Stopped (1503); Battery Problem (2885)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/27/2021 |
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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, model #: 1420-controller, catalog #: 1420-controller, expiration date: 30-nov-2018, serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Mfg date: 17-nov-2017.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420-controller, catalog #: 1420-controller, expiration date: 31-aug-2019, serial #: (b)(4), udi #: (b)(4), device available for evaluation: no.Mfg date: 27-aug-2018.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery, model #: 1650de, catalog #: 1650de, expiration date: 30-jun-2022, serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Mfg date: 14-jun-2021.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery, model #: 1650de, catalog #: 1650de, expiration date: 30-jun-2022, serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Mfg date: 14-jun-2021.Labeled for single use: no.(b)(4).Additional information has been requested regarding the log files for this event, but it was not available at the time of this report.If log files investigation is performed, the event will be updated and a supplemental report will be sent.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 there were multiple critical battery alarms and ventricular assist device (vad) stops.When the controller was exchanged the vad was said to fail to restart.It was stated that the back up controller looked like it attempted to start the vad from the log files, but the vad never restarted.The patient had no medical symptoms that were known of.The patient was transported to the hospital.No treatment or intervention was performed.The patient subsequently expired.
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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.Additional products: (b)(6) h3: yes h6:fda method code(s): b15, b01 h6:fda result code(s):c19, c15 h6:fda conclusion code(s): d11, d15, d10 (b)(6) h3: yes h6:fda method code(s): b15, b01 h6:fda result code(s):c19, c15 h6:fda conclusion code(s): d11, d10 (b)(6) h3: yes h6:fda method code(s): b15, b01 h6:fda result code(s):c19 h6: fda conclusion code(s): d14 (b)(6) h3: yes h6:fda method code(s): b15, b01 h6:fda result code(s):c07 h6:fda conclusion code(s): d11 product event summary: the ventricular assist device (vad) (b)(6), two (2) controllers (b)(6), and two (2) batteries (b)(6) were returned for evaluation.A review of the pump¿s manufacturing documentation confirmed that the associated device met all requirements for release.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 and functional testing.Dimensional verification revealed that the rear housing disc curvature and front housing disc curvature were found to be deviating from release specifications.Tissue was observed upon opening of the returned pump; however, the sample could not be retrieved for pathological evaluation since it was falling apart.Failure analysis of the returned controllers (b)(6) revealed that the devices passed functional testing.Visual inspection of controller (b)(6) revealed contamination within both power ports and the pump connector.Visual inspection of controller (b)(6) revealed contamination within the pump connector.The observed contamination is an additional finding not related to the reported event and likely due to handling of the devices.Failure analysis of the returned battery (b)(6) revealed that the battery passed visual inspection and functional testing.Failure ana lysis of the returned battery (b)(6) revealed that the battery cable connector was damaged, as the locking mechanism ring was missing from the connector.The battery was still able to charge and provide power to a test controller; however, the observed damage prevented the battery from performing proper mating and locking to the power ports of the test controller.The observed battery connector damage is additional finding not related to the reported event and likely due to handling of the device.Capa pr00405633 is investigating damage to power sources.Log file analysis revealed that (b)(6) was the patient's primary controller in use during the reported event.Review of the controller log files associated with (b)(6) revealed several vad stopped alarms, vad disconnect alarms, critical battery alarms, and controller power up events on 27/nov/2021.A vad stopped alarm was logged at 21:30:20, indicating that the pump failed to restart after multiple attempts.The controller contains a feature that records a data point in 15-minute intervals.Review of the data file revealed that the data points prior to and after the initial vad stopped alarm, logged at 21:30:20, are 4 minutes and 56 seconds apart, which is indicative that the controller logged a data point following a power up sequence, since the controller will log a data point approximately 40 seconds after a power up event, indicating that the controller lost power at some between 21:25:42 and 21:30:38.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 42% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 24% 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 for a maximum of 4 minutes and 56 seconds.The controller can only store a maximum of 250 entries of event data.After reaching the limit, the controller initiates a first-in first-out method whereby the oldest event point is deleted to allow the newest entries to be recorded.Therefore, event logs prior to the first available controller power-up event, logged at 22:23:34, were not available.This was followed by several additional vad stopped alarms due to the failure of the pump to restart, in addition to several vad disconnect alarms and controller power up events, likely due to troubleshooting.A review of the alarm log files also revealed 13 critical battery alarms logged involving (b)(6) on 27/nov/2021, from 22:33:51 through 22:37:35, due to the battery depleting below 10% rsoc.Analysis of the alarm log file revealed that during the vad disconnect alarm at 22:23:08, indicating a physical disconnection of the driveline from the controller, the battery recorded a battery capacity of 20% rsoc.At the time of the first c ritical battery alarm at 22:33:51, (b)(6) was connected to power port two (2) with 9% rsoc and no power source was connected to power port one (1).It was also noted that the pump exhibited high power consumption during the observed alarms, due to the multiple attempted motor start events.A safety alert word (saw) value was recorded indicating an overcurrent alert, which required more current from the batteries.Per the instructions for use (ifu), the capacity of a battery is dependent on the controller and pump operating power consumption.Based on the available information, the high power consumption during the attempted motor starts likely caused the battery to rapidly deplete, resulting in the critical battery alarm when the battery depleted below 10% rsoc.Review of the controller log files associated with (b)(6) revealed a controller power-up event logged on 27/nov/2021 at 22:58:54; prior to the power up event, the controller last had power on 04/oct/2021, indicating that the controller was put into use following the reported controller exchange.A vad stopped alarm was logged at 22:59:12, indicating that the pump failed to restart after multiple attempts.This was followed by several additional vad stopped alarms due to the failure of the pump to restart, in addition to several vad d isconnect alarms and controller power up events, likely due to troubleshooting.As a result, the reported event was confirmed.The most likely root cause of the reported critical battery alarms event can be attributed to the battery depleting below 10% rsoc during the observed attempted motor start events.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.The most likely root cause of the vad stopped alarm can be attributed to a failure of the pump to restart after several attempts.(b)(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 correction is being submitted for inclusion of this event as being in-scope for recall with z-0946-2021.This event was submitted historically and has been deemed in-scope for the field corrective action.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 analysis.Product event summary: (b)(6), two (2) controllers ((b)(6)), and two (2) batteries ((b)(6)) were returned for evaluation.A review of the pump¿s manufacturing documentation confirmed that the associated device met all requirements for release.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 and functional testing.Dimensional verification revealed that the rear housing disc curvature and front housing disc curvature were found to be deviating from release specifications.Tissue was observed upon opening of the returned pump; however, the sample could not be retrieved for pathological evaluation since it was falling apart.Failure analysis of the returned controllers (b)(6) revealed that the devices passed functional testing.Visual inspection of controller (b)(6) revealed contamination within both power ports and the pump connector.Visual inspection of controller (b)(6) revealed contamination within the pump connector.The observed contamination is an additional finding not related to the reported event and likely due to handling of the devices.Failure analysis of the returned battery (b)(6)revealed that the battery passed visual inspection and functional testing.Failure analysis of the returned battery (b)(6) revealed that the battery cable connector was damaged, as the locking mechanism ring was missing from the connector.The battery was still able to charge and provide power to a test controller; however, the observed damage prevented the battery from performing proper mating and locking to the power ports of the test controller.The observed battery connector damage is additional finding not related to the reported event and likely due to handling of the device.Log file analysis revealed that (b)(6) was the patient's primary controller in use during the reported event.Review of the controller log files associated with (b)(6) revealed several vad stopped alarms, vad disconnect alarms, critical battery alarms, and controller power up events on 27/nov/2021.A vad stopped alarm was logged at 21:30:20, indicating that the pump failed to restart after multiple attempts.The controller contains a feature that records a data point in 15-minute intervals.Review of the data file revealed that the data points prior to and after the initial vad stopped alarm, logged at 21:30:20, are 4 minutes and 56 seconds apart, which is indicative that the controller logged a data point following a power up sequence, since the controller will log a data point approximately 40 seconds after a power up event, indicating that the controller lost power at some between 21:25:42 and 21:30:38.The data point prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 42% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 24% 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 for a maximum of 4 minutes and 56 seconds.The controller can only store a maximum of 250 entries of event data.After reaching the limit, the controller initiates a first-in first-out method whereby the oldest event point is deleted to allow the newest entries to be recorded.Therefore, event logs prior to the first available controller power-up event, logged at 22:23:34, were not available.During this period, a safety alert word (saw) value was recorded on the only connected power source, (b)(6), indicating an overcurrent alert.During the attempted pump start events, the data log file recorded high power consumption, which required more current from the battery.It is likely that the overcurrent condition prevented the battery from providing power, resulting in additional losses of power to the controller.This was followed by several additional vad stopped alarms due to the failure of the pump to restart, in addition to several vad disconnect alarms and controller power up events, likely due to troubleshooting.During at tempted pump start events, several controller reset events were logged on 27/nov/2021.A review of the alarm log files also revealed 13 critical battery alarms logged involving (b)(6) on 27/nov/2021, from 22:33:51 through 22:37:35, due to the battery depleting below 10% rsoc.Analysis of the alarm log file revealed that during the vad disconnect alarm at 22:23:08, indicating a physical di sconnection of the driveline from the controller, the battery recorded a battery capacity of 20% rsoc.At the time of the first critical battery alarm at 22:33:51, (b)(6) was connected to power port two (2) with 9% rsoc and no power source was connected to power port one (1).It was also noted that the pump exhibited high power consumption during the observed alarms, due to the multiple attempted motor start events.A safety alert word (saw) value was recorded indicating an overcurrent alert, which required more current from the batteries.Per the instructions for use (ifu), the capacity of a battery is dependent on the controller and pump operating power consumption.Based on the available information, the high power consumption during the attempted motor starts likely caused the battery to rapidly deplete, resulting in the critical battery alarm when the battery depleted below 10% rsoc.Review of the controller log files associated with (b)(6) revealed a controller power-up event logged on 27/nov/2021 at 22:58:54; prior to the power up event, the controller last had power on 04/oct/2021, indicating that the controller was put into use following the reported controller exchange.A vad stopped alarm was logged at 22:59:12, indicating that the pump failed to restart after multiple attempts.This was followed by several additional vad stopped alarms due to the failure of the pump to restart, in addition to several vad disconnect alarms and controller power up events, likely due to troubleshooting.As a result, the reported event was confirmed.The most likely root cause of the reported critical battery alarms event can be attributed to the battery depleting below 10% rsoc during the observed attempted motor start events.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 losses of power during pump start due to battery discharge overcurrent condition.Capa pr00609659 is investigating controller resets during pump start.The most likely root cause of the vad stopped alarm can be attributed to a failure of the pump to restart after several attempts.(b)(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.H6: the codes present in section h6 correspond to components/products that comprise the reported event.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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