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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); Battery Problem (2885); Power Problem (3010)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 07/19/2022 |
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Event Type
malfunction
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Event Description
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It was reported that two controllers exhibited unexpected losses of power.It was reported that one of the controllers also exhibited a controller fault alarm.The controllers 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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Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products:heartware ventricular assist system -controller 2.0 model #: 1420 / catalog #: 1420 / expiration date: 31-dec-2022 / serial #: (b)(4) udi #: (b)(4) device available for evaluation,no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 09-12-2021 labeled for single use: no.(b)(4):additional information has been requested regarding event details, 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.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.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 both controllers exhibited controller fault alarms due to internal battery expiration.It was also reported that the controller losses of power were due to patient error.The controllers were exchanged.
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Manufacturer Narrative
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A supplemental is being submitted for additional information.Additional products: (b)(6) -controller 2.0 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 product event summary: two (2) controllers ((b)(6)) were not returned for evaluation.Log file analysis revealed that (b)(6) was the primary controller, initially in use during the reported event date.Log files associated with (b)(6)also revealed a controller power up with an associated pump start event on 19-jul-2022 at 15:13:56.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 91% of relative state of charge (rsoc).The data point recorded after 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).No anomalies were observed leading up to the loss of power.The controller was without power for 14 seconds.Log file analysis associated with (b)(6) revealed that a controller fault alarm was logged on 19-jul-2022 at 15:51:21 and multiple event exceptions were recorded, indicating an issue with the internal battery.Log files also revealed that (b)(6) was in use for more than two (2) years.Additionally, log files associated with (b)(6) revealed a vad disconnect alarm ind icating a physical disconnection of the driveline from the controller and a controller power up without a motor start event were logged on as logged on 19-jul-2022 since 16:57:15, likely due to troubleshooting during a controller exchange.Log file analysis associated with (b)(6) revealed two (2) controller power up events were logged on 19-jul-2022 at 16:51:10 and 16:54:56 with an associated pump start event logged on 19-jul-2022 at 16:54:56.Review of the data log file revealed that the controller (b)(6) was not in use prior to the controller power up event; the first data point was logged on 19-jul-2022 at 16:55:32, indicating that the power up events occurred during a controller exchange.As a result, the reported loss of power and controller fault alarm events associated with (b)(6) were confirmed.The reported controller power up event associated (b)(6) was confirmed.With applicable risk documentation, experience with events of similar circumstances, and the available information were considered; a possible root cause of the reported controller fault alarm event may be attributed, but not limited, to a reduced charge capacity o f the internal battery and/or a faulty internal battery charger integrated circuit.Possible root cause of the loss of power event 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 pr00551638 is investigating controller losses of power.Based on the available information, the most likely root cause of the controller power up events involving (b)(6) can be attributed to a controller exchange.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 both controllers exhibited controller fault alarms due to internal battery expiration.It was also reported that the controller losses of power were due to patient error.The controllers were exchanged.
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Manufacturer Narrative
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A supplemental report is being submitted for device analysis.Product event summary: two (2) controllers (b)(6) were not returned for evaluation.Log file analysis revealed that (b)(6) was the primary controller, initially in use during the reported event date.Log files associated with (b)(6) also revealed a controller power up with an associated pump start event on 19-jul-2022 at 15:13:56.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 91% of relative state of charge (rsoc).The data point recorded after 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).No anomalies were observed leading up to the loss of power.The controller was without power for fourteen (14) seconds.Log file analysis associated with (b)(6) revealed that a controller fault alarm was logged on 19-jul-2022 at 15:51:21 and multiple event exceptions were recorded, indicating an issue with the internal battery.Log files also revealed that (b)(6) was in use for more than two (2) years.Additionally, log files associated with (b)(6) revealed a vad disconnect alarm indicating a physical disconnection of the driveline from the controller and a controller power up without a motor start event were logged on as logged on 19-jul-2022 since 16:57:15, likely due to troubleshooting during a controller exchange.Log file analysis associated with con417496 revealed two (2) controller power up events were logged on 19-jul-2022 at 16:51:10 and 16:54:56 with an associated pump start event logged on 19-jul-2022 at 16:54:56.Review of the data log file revealed that the controller (b)(6) was not in use prior to the controller power up event; the only data point was logged on 19-jul-2022 at 16:55:32, indicating that the power up events occurred during a controller exchange.The alarm log file associated with (b)(6) was not available for analysis.In addition, log files indicated that (b)(6) was programmed by the site on 19-jul-2022.Log file analysis did not reveal any controller fault alarms involving (b)(6) within the analyzed period.As a result, the reported accidental loss of power and controller fault alarm events associated with (b)(6) were confirmed.The reported loss power and controller fault alarm associated with (b)(6) could not be confirmed.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; a possible root cause of the reported controller fault alarm event may be attributed, but not limited, to a reduced charge capacity of the internal battery and/or a faulty internal battery charger integrated circuit.Possible root cause of the loss of power event involving (b)(6) can be attributed to reported disconnection of both power sources from the controller as described in the event details.Capa pr00551638 is investigating controller losses of power.Based on the available information, the most likely root cause of the controller power up events involving (b)(6) can be attributed to a controller exchange.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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