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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Disconnection (1171); Electrical /Electronic Property Problem (1198); Failure to Pump (1502); Power Problem (3010)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 08/22/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Additional products: brand name: heartware ventricular assist system ¿ controller 2.0.Model #: 1420 / catalog #: 1420 / expiration date: 28-feb-2019 / serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: no.No, device evaluation anticipated, but not yet begun mfg date: 28-feb-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 driveline became disconnected.Upon reconnecting, there was an electrical fault potentially due to bad or incomplete driveline connection.A failure to start was then noted.The controller then restarted but no driveline connection was noted.The controller later powered up and the ventricular assist device (vad) started.The driveline and controller remain in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This supplemental is being submitted for additional information received stating that one of the controllers (con319372) is being returned for analysis.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 the controller on which electrical fault alarms were noted was exchanged.
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Event Description
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It was further reported that another controller exhibited an unexpected loss of power.The controller remains in use.
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Manufacturer Narrative
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A supplemental is being submitted for a correction to add an additional device involved with this event.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model#: 1420 / catalog#: 1420 / expiration date: 28-feb-2019 / serial or lot#: (b)(6) / udi#: (b)(4) / d10: no / h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 28-feb-2018 h5: no h6: patient code(s): c50675 h6: device code(s): c63025 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.
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Manufacturer Narrative
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This supplemental is being submitted for additional information received.The device code for (b)(6) was changed to c63025.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 also noted that the controller with the electrical fault alarms also exhibited an unexpected loss of power.
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Manufacturer Narrative
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This supplemental is being submitted as a correction to add information to the event description and coding for the ventricular assist device (vad)/driveline in section h6 device codes.There is also additional information capturing the return of the controller (b)(6) on (b)(6) 2020.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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Manufacturer Narrative
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A supplemental report is being submitted for device evaluation.The ventricular assist device (vad) and one controller (con319372) were not returned for evaluation.One controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection revealed a missing serial port cap.This is an additional finding not related to the reported event, likely due to handling of the device.Visual inspection did not reveal any signs of contamination within the driveline connector.During supplemental testing, the controller was connected to a test motor and allowed to run for an extended period of time; results revealed that the driveline port functioned as intended and the electrical fault alarm could not be replicated.Log file analysis revealed that the returned controller was the patient's primary controller, initially in use at the time of the event.Analysis of the event log file associated with this controller revealed a controller power up event on 22/aug/2020 at 14:21:37.Analysis of the controller's alarm log file revealed one vad disconnect alarm, one electrical fault alarm, and one vad stopped alarm logged on 27/aug/2020.A vad disconnect alarm was logged at 17:05:16 due to open phases on both stators.An electrical fault alarm was then logged at 17:05:33, indicating that the rear stator was not connected.A vad stopped alarm was logged at 17:06:03 due to a failure of the pump to restart after several attempts.Additionally, a controller power up event without an associated motor start event was logged on 27/aug/2020 at 17:22:45, likely due to troubleshooting during the reported controller exchange.Log file analysis revealed that a controller exchange was then performed, after which a different controller was in use.Review of the log files associated with controller 2 revealed a controller power up event logged on 27/aug/2020 at 16:32:30 with a successful motor start at 16:32:37.Review of the event log file revealed that, prior to the power up event, the controller last had power on 24/jul/2019.Additionally, review of the data log file revealed that the controller was not in use prior to the controller power up event; the first data point recorded since 24/jul/2019 was logged at 16:33:03 on 27/aug/2020, indicating that the power up event occurred during a controller exchange.Of note, based on the available information, the time set on controller 2 was likely incorrect, as it was reported that the power up event occurred after the electrical fault and failure to restart.As a result, the reported events were confirmed.A possible root cause of the initial loss of power involving the first controller can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Based on the available information, the most likely root cause of the reported controller power up event involving controller 2 can be attributed to a controller exchange.Based on risk documentation and the available information, a possible root cause of the reported vad disconnect alarm and electrical fault alarm event can be attributed, but not limited, to a marginal driveline connection or contamination by foreign material of the driveline connector.The most likely root cause of the vad stopped alarm can be attributed to failure of the pump to restart after several attempts.An internal investigation was opened to investigate pump failures to restart.Additional products: d4: serial#: con319376 d9: yes, 2020-09-22 h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04, c070603 h6: fda conclusion code(s): d10, d11 d4: (b)(6) h3: yes h6: fda method code(s): b15, b17 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.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 a correction.Corrected fields: h1 type of report: updated to serious injury b5 event description was updated additional codes: imf code was updated to f08 b1 adv event/product problem updated this regulatory report is being submitted as part of a retrospective review and remediation per d00595827 due to an fda audit observation.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 reported that the driveline became disconnected.The patient was hospitalized.Upon reconnecting, there was an electrical fault potentially due to bad or incomplete driveline connection.A failure to start was then noted.The controller then restarted but no driveline connection was noted.The controller later powered up and the ventricular assist device (vad) started.The controller also exhibited an unexected power loss.The driveline and controller remain in use.It was further reported that another controller exhibited an unexpected loss of power.The controller remains 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 for device evaluation and updates to the investigation summary.Revised product event summary: the pump and one (1) controller were not returned for evaluation.One (1) controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection revealed a missing serial port cap.This is an additional finding not related to the reported event, likely due to handling of the device.Visual inspection did not reveal any signs of contamination within the driveline connector.During supplemental testing, the controller was connected to a test motor and allowed to run for an extended period of time; results revealed that the driveline port functioned as intended and the electrical fault alarm could not be replicated.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use at the time of the event.Analysis of the event log file associated with (b)(6) revealed a controller power up event on (b)(6) 2020 at 14:21:37.The data point logged in the controller's internal logs prior to the loss of power revealed that (b)(6) was connected to power port one (1) with 25% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 28% rsoc.The data point recorded after the loss of power revealed that bat757915 was connected to power port one (1) and (b)(6) was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for 13 seconds.Analysis of (b)(6) alarm log file revealed one (1) vad disconnect alarm, one (1) electrical fault alarm, and one (1) vad stopped alarm logged on (b)(6) 2020.A vad disconnect alarm was logged at 17:05:16 due to open phases on both stators.An electrical fault alarm was then logged at 17:05:33, indicating that the rear stator was not connected.A vad stopped alarm was logged at 17:06:03 due to a failure of the pump to restart after several attempts.Additionally, a controller power up event without an associated motor start event was logged on (b)(6) 2020 at 17:22:45, likely due to troubleshooting during the reported controller exchange.Log file analysis revealed that a contr oller exchange was then performed, after which (b)(6) was in use.Review of the log files associated with (b)(6) revealed a controller power up event logged on (b)(6) 2020 at 16:32:30 with a successful motor start at 16:32:37.Review of the event log file revealed that, prior to the power up event, the controller last had power on (b)(6) 2019.Additionally, review of the data log file revealed that the controller was not in use prior to the controller power up event; the first data point recorded since (b)(6) 2019 was logged at 16:33:03 on (b)(6) 2020, indicating that the power up event occurred during a controller exchange.Of note, based on the available information, the time set on (b)(6) was likely incorrect, as it was reported that the power up event occurred after the electrical fault and failure to restart.As a result, the reported events were confirmed.A possible root cause of the initial loss of power involving (b)(6) can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa (b)(4) is investigating controller losses of power.Based on the available information, the most likely root cause of the reported controller power up event involving (b)(6) can be attributed to a controller exchange.Based on risk documentation and the available information, a possible root cause of the reported vad disconnect alarm and electrical fault alarm event can be attributed, but not limited, to a marginal driveline connection or contamination by foreign material of the driveline connector.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) was not in scope of fca cvg-21-q3-21.Capa (b)(4) 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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