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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1420 |
| Device Problems
Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/05/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Additional information has been requested regarding the serial number of the controller and any intervention taken to secure the data port, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.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 data port was pulled out of the controller and was held together by wires.No alarms were reported to have occurred and the controller was still able to be connected to a monitor.The controller remains in use.No 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 for additional information.Newly received information provided the intervention performed for the controller with the broken port, the controller exchanged and subsequent vad stop alarm, and the medical preparation the patient underwent for the exchange.Additional products: d1: heartware ventricular assist system ¿ pump / d4: model#: 1103 / catalog#: 1103 / expiration date: 30-apr-2021 / serial#: (b)(6) / udi #: (b)(4) / d6a: implanted date: on (b)(6) 2019 / d9: no / h3: no, device evaluation anticipated, but not yet begun / h4: mfg date: 03-apr-2019 / h5: yes / h6: patient ime code(s): e2403 h6: imf code(s): f2303, f08, f12, f2203 h6: img code(s): g04105 h6: fda device code(s): a1412, a141203 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 / d1: heartware ventricular assist system ¿ controller 2.0 / d4: model#: 1420 / catalog #: 1420 / expiration date: 30-apr-2022 / serial#: (b)(6) / udi #: (b)(4) / d9: no / h3: no, device evaluation anticipated, but not yet begun / h4: mfg date: 21-apr-2021 / h5: no / h6: patient ime code(s): e2403 h6: imf code(s): f2303, f08, f12, f2203 h6: img code(s): g04035 h6: fda device code(s): a141204 h6: fda results code(s): c21 h6: fda conclusion code(s): d16.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.
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Event Description
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It was further reported that electrical fault and high watt alarms occurred after an attempt to push the data port back into the controller housing.The ventricular assist device (vad) also exhibited above normal power consumption.It was noted that initially the decision was made not to exchange the controller due to concerns for the pump failing to restart.The data port was temporarily secured with tape and the alarm was silenced.Six days after the issue was originally observed and it was noted that there was risk for water ingress, the controller was exchanged.During the exchange, the patient was connected to two monitors, one for each controller, and a controller ac adapter was connected to each of the controllers.Approximately one minute and four seconds after the controller was exchanged, a vad stop alarm occurred (after five cycle attempts).The controller was again exchanged.It was noted that power and a monitor were already connected to the new controller so that the driveline could be disconnected from the controller and connected to the new controller.The vad started immediately without incidence.The patient tolerated the controller exchange well and noted that they did not feel any different.The patient had been on two micrograms dobutamine and a heparin drip prior to and during the controller exchange.After the exchange, the dobutamine and heparin were stopped and an echocardiogram was performed.The echocardiogram remained unchanged from previous and the patient continued to do well overnight with no events.The vad remains in use.No further patient complications have been reported as a result of this event.
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Event Description
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It was further reported that the new replacement controller had a new algorithm.
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Manufacturer Narrative
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A supplemental report is being submitted for additional event details.The event description was updated with additional information about the new algorithm that was on the new replacement controller.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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Manufacturer Narrative
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### a supplemental report is being submitted for device evaluation and investigation completion.Product event summary: the pump ((b)(6)) was not returned for evaluation.The three controllers ((b)(6)) were returned for evalu ation.A review of (b)(6)'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 returned devices in relation to the reported event.Failure analysis of (b)(6) and (b)(6) revealed that the controllers passed visual inspection and functional testing.Visual inspection of the (b)(6) revealed contamination in the serial port and that the serial cap was missing.These are additional findings not related to the reported event.The most likely root cause of the observed contamination and missing serial cap can be attributed to the handling of the device.Failure analysis of (b)(6) and visual evidence provided by the site revealed a loose, detached serial port connector.An internal inspection revealed a loose metal locknut and washer from the serial port in the controller; internal inspection did not reveal any evidence of fluid ingress.A visual inspection under 10x magnification revealed the absence of the loctite substance on the connector thread, resulting in the loose components.After the loose components were removed, the controller was able to power the test motor without anomalies.Review of the controller alarm log file associated with (b)(6) revealed two electrical fault alarms and one high watt alarm were logged on (b)(6) 2022.The electrical fault alarms logged at 16:45:55 and 19:43:23 were indicating an overcurrent condition on the front stator resulting in the pump running on a single stator.This likely triggered the subsequent high watt alarm and increase in power consumption since (b)(6) 2022 above the normal operating range, due to the increased power consumption required to run on a single stator.Review of the event log file associated with (b)(6) also revealed four reactivation events on (b)(6) 2022 between 16:45:38 and 16:45:59 due to an overcurrent condition detected on the front stator.Additionally, log files as sociated with (b)(6) revealed controller power up events and a vad disconnect alarm indicating a physical disconnection of the driveline from the controller, were logged on (b)(6) 2022 since 16:34:35, likely due to troubleshooting of the controller and/or the r eported controller exchange.Analysis indicated that the loose locknut likely caused a short circuit condition between the printed circuit board and the front motor driver circuit that operates a front stator, resulting in single stator operation during the reported event.Log file analysis associated with (b)(6) revealed that the controller was not in use during the reported event date and was likely being used as a back-up controller.Log file analysis associated with (b)(6) revealed two controller power up events logged on (b)(6) 2022 at 15:26:45 and 15:50:23.Various parameters, including time, patient id, and pump id were programmed between the controller power up events, indicating the power up events occurred during a controller exchange.Analysis of the alarm log file associated with (b)(6) revealed a vad stopped alarm logged on (b)(6) 2022 at 15:58:23, indicating that the pump failed to restart after multiple attempts.This vad stopped alarm was followed by an additional controller power up event, likely due to troubleshooting.As a result, the reported loose power, high power, electrical fault alarm, and vad stop events were confirmed.The most likely root cause of the reported loose serial port event can be attributed to improper assembly.Capa (b)(4) was opened to investigate loose connectors with controller 2.0.Based on the investigation conducted, the most likely root cause of the reported electrical fault alarms, high watt alarms, high power, and observed reactivation events can most likely be attributed to the loose locknut coming in contact with the controller's printed circuit board.The most likely root cause of the vad stopped alarm can be attributed to failure of the pump to restart after several attempts.(b)(6) is part of fca cvg-21-q3-21.Capa (b)(4) is investigating pump failures to restart.Additional products: d4: serial #: (b)(6) d10: yes, return date: 13-apr-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d4: serial or lot#: (b)(6) h3: yes h5: yes h6: fda method code(s): b15,b17 h6: fda results code(s): c07 h6: fda conclusion code(s): d01, d12 d4: serial #: (b)(6) d10: yes, return date: 13-apr-2022 h3:yes dev rtn to mfr? yes h6: img code(s): g04035 h6: fda method code(s): b01,b15 h6: fda results code(s): c19 h6: fda conclusion code(s): 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.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.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Three (3) controllers were returned for evaluation.A review of (b)(6) 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 returned devices in relation to the reported event.Failure analysis of (b)(6) and (b)(6) revealed that the controllers passed visual inspection and functional testing.Visual inspection of the (b)(6) revealed contamination in the serial port and that the serial cap was missing.These are additional findings not related to the reported event.The most likely root cause of the observed contamination and missing serial cap can be attributed to the handling of the device.Failure analysis of (b)(6) and visual evidence provided by the site revealed a loose, detached serial port connector.An internal inspection revealed a loose metal locknut and washer from the serial port in the controller; internal inspection did not reveal any evidence of fluid ingress.A visual inspection under 10x magnification revealed the absence of the loctite substance on the connector thread, resulting in the loose components.After the loose components were removed, the controller was able to power the test motor without anomalies.Review of the controller alarm log file associated with (b)(6) revealed two (2) electrical fault alarms and one (1) high watt alarm were logged on (b)(6) 2022.The electrical fault alarms logged at 16:45:55 and 19:43:23 were indicating an overcurrent condition on the front stator resulting in the pump running on a single stator.This likely triggered the subsequent high watt alarm and increase in power consumption since (b)(6) 2022 above the normal operating range, due to the increased power consumption required to run on a single stator.Review of the event log file associated with (b)(6) also revealed four (4) reactivation events on (b)(6) 2022 between 16:45:38 and 16:45:59 due to an overcurrent condition detected on the front stator.Additionally, log files associated with (b)(6) revealed controller power up events and a vad disconnect alarm indicating a physical disconnection of the driveline from the controller, were logged on (b)(6) 2022 since 16:34:35, likely due to troubleshooting of the controller and/or the reported controller exchange.Analysis indicated that the loose locknut likely caused a short circuit condition between the printed circuit board and the front motor driver circuit that operates a front stator, resulting in single stator operation during the reported event.Log file analysis associated with (b)(6) revealed that the controller was not in use during the reported event date and was likely being used as a back-up controller.Log file analysis associated with con416411 revealed two controller power up events logged on (b)(6) 2022 at 15:26:45 and 15:50:23.Various parameters, including time, patient id, and pump id were programmed between the controller power up events, indicating the power up events occurred during a controller exchange.Analysis of the alarm log file associated with (b)(6) revealed a vad stopped alarm logged on (b)(6) 2022 at 15:58:23, indicating that the pump failed to restart after multiple attempts.This vad stopped alarm was followed by an additional controller power up event, likely due to troubleshooting.As a result, the reported loose data/serial port, "controller fault associated with single stator operation", high power, electrical fault alarm, and vad stop events were confirmed.The most likely root cause of the reported loose serial port event can be attributed to improper assembly.Capa (b)(4) was opened to investigate loose connectors with controller 2.0.Based on the investigation conducted, the most likely root cause of the reported electrical fault alarms, single stator operation, high watt alarms, high power, and observed reactivation events can most likely be attributed to the loose locknut coming in contact with the controller's printed circuit board.The most likely root cause of the vad stopped alarm 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.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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Event Description
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It was further reported that a controller fault occurred and of note the vad maintained set speed but was operating on one stator.
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Manufacturer Narrative
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A supplemental report is being submitted for an update to: -b5.Desc evt problem.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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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 additional event details and corrections to a5a, a5b, and b7.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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Event Description
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It was further reported by the patient's spouse that the controller had a bent pin.Upon inspection by a company representative, it was noted that the controller did not have any bent pins, but one of the controller ports was disengaged.
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Manufacturer Narrative
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A supplemental report is being submitted for an update to the product event summary.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Three controllers were returned for evaluation.A review of (b)(6)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 returned devices in relation to the reported event.Failure analysis of (b)(6) and (b)(6) revealed that the controllers passed visual inspection and functional testing.Visual inspection of the (b)(6) revealed contamination in the serial port and that the serial cap was missing.These are additional findings not related to the reported event.The most likely root cause of the observed contamination and missing serial cap can be attributed to the handling of the device.Failure analysis of (b)(6) and visual evidence provided by the site revealed a loose, detached serial port connector.An internal inspection revealed a loose metal locknut and washer from the serial port in the controller; internal inspection did not reveal any evidence of fluid ingress.A visual inspection under 10x magnification revealed the absence of the loctite substance on the connector thread, resulting in the loose components.After the loose components were removed, the controller was able to power the test motor without anomalies.In addition, visual inspection did not reveal any bent pins within the connectors.Review of the controller alarm log file associated with (b)(6) revealed two (2) electrical fault alarms and one high watt alarm were logged on 07-mar-2022.The electrical fault alarms logged at 16:45:55 and 19:43:23 were indicating an overcurrent condition on the front stator resulting in the pump running on a single stator.This likely triggered the subsequent high watt alarm and increase in power consumption since 07-mar-2022 above the normal operating range, due to the increased power consumption required to run on a single stator.Review of the event log file associated with (b)(6) also revealed four reactivation events on 07-mar-2022 between 16:45:38 and 16:45:59 du e to an overcurrent condition detected on the front stator.Additionally, log files associated with (b)(6) revealed controller power up events and a vad disconnect alarm indicating a physical disconnection of the driveline from the controller, were logged on 11 -mar-2022 since 16:34:35, likely due to troubleshooting of the controller and/or the reported controller exchange.Analysis indicated that the loose locknut likely caused a short circuit condition between the printed circuit board and the front motor driver circuit that operates a front stator, resulting in single stator operation during the reported event.Log file analysis associated with (b)(6) revealed that the controller was not in use during the reported event date and was likely being used as a back-up controller.Log file analysis associated with (b)(6) revealed two controller power up events logged on 11-mar-2022 at 15:26:45 and 15:50:23.Various parameters, including time, patient id, and pump id were programmed between the controller power up events, indicating the power up events occurred during a controller exchange.Analysis of the alarm log file associated with con416411 revealed a vad stopped alarm logged on 11-mar-2022 at 15:58:23, indicating that the pump failed to restart after multiple attempts.This vad stopped alarm was followed by an additional controller power up event, likely due to troubleshooting.As a result, the reported loose data/serial port, "controller fault associated with single stator operation", high power, electrical fault alarm, and vad stop events were confirmed.The reported bent pin event was not confirmed.The most likely root cause of the reported loose serial port event can be attributed to improper assembly.Capa pr00508470 was opened to investigate loose connectors with controller 2.0.Based on the investigation conducted, the most likely root cause of the reported electrical fault alarms, single stator operation, high watt alarms, high power, and observed reactivation events can most likely be attributed to the loose locknut coming in contact with the controller's printed circuit board.The most likely root cause of the vad stopped alarm 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.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.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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