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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
Failure to Pump (1502); Pumping Stopped (1503); Battery Problem (2885); 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 09/12/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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Additional products: heartware ventricular assist system: controller.Model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2019 / serial#: (b)(4), udi #: 00888707000475, concomitant medical products/therapy dates? no.Device evaluated by mfr? no, device evaluation anticipated, but not yet begun.Mfg date: 30-jan-2018, labeled for single use? no.(b)(4).Heartware ventricular assist system: controller.Model#: 1420 / catalog #: 1420 / expiration date: 31-jan-2019 / serial #: (b)(4), udi #: (b)(4), concomitant medical product/therapy dates? no.Device evaluated by mfr? no, device evaluation anticipated, but not yet begun.Mfg date: 30-jan-2018, labeled for single use? no.(b)(4).Heartware ventricular assist system: battery.Model #: 1650de / catalog #: 1650de / expiration date: 31-may-2019 / serial #: (b)(4), udi #: (b)(4), concomitant medical product: no.Device evaluated by mfr? no, device evaluation anticipated, but not yet begun.Mfg date: 31-may-2018, labeled for single use? no.(b)(4).Concomitant medical product: 6935m55 lead, implanted: (b)(6) 2018, dvfb1d4 icd, implanted: (b)(6) 2018, investigation of this event is pending, and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient accidentally disconnected a battery from their primary controller.After reapplying the power source, a ventricular assist device (vad) stop alarmed, and the controller exhibited an unexpected power loss.The patient then switched to their back up controller, however, the vad stop alarms continued, and the backup controller unexpected power losses, and the battery exhibited a power disconnect with an alarm.The patient then swapped to a third controller, and the vad began to operate normally.With concern about the vad being off for an extended period and the inability for multiple controllers to restart pump, the patient was placed in observation.The controllers, and battery 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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A supplemental report is being submitted for device evaluation product event summary: conclusion: three controllers and one battery were not returned for evaluation.Review of the controller log files associated with the controller revealed that a controller power up event was logged on (b)(6) 2020 at 12:27:09.Review of the event log file revealed that, prior to the power up event, the controller last had power on (b)(6) 2019, indicating that the controller was likely the patient¿s backup controller.A vad disconnect alarm was logged following the controller power up at 12:27:16, indicating that the controller was powered up without the driveline cable connected.Log file analysis revealed that another controller was the patient's primary controller.Review of the controller log files associated with another controller revealed controller power up events on (b)(6) 2020 at 13:01:28 and 13:01:57.The data point prior to the losses of power revealed that the battery was connected to power port one with 34% relative state of charge (rsoc) and no power source was connected to power port two.The data point recorded after the losses of power revealed that (b)(6) was connected to power port one and the battery was connected to power port two.No anomalies were observed leading up to the loss of power.The controller was without power for a maximum of 43 seconds.A vad stopped alarm was then logged at 13:02:36 due to a failure of the pump to restart after several attempts.This was followed by several additional controller power up events and vad disconnect alarms, indicating physical disconnections of the driveline from the controller, logged between 13:02:49 and 13:13:11, likely due to troubleshooting.Multiple additional vad stopped alarms were logged during this period, indicating that, on each occasion, the pump failed to restart after multiple attempts.Additionally, a power disconnect alarm was logged on (b)(6) 2020 at 13:14:50 involving (b)(6).During the power disconnect alarm, a safety alert word (saw) value was recorded indicating an overcurrent alert.The event log recorded a high-power consumption during the attempted motor starts, which required more current from the batteries.The battery was most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.Log file analysis revealed that a controller exchange was then performed, after which the other controller was in use.A controller power up event was logged on (b)(6) 2020 at 13:17:00.A vad disconnect alarm was logged following the controller power up, at 13:17:07, indicating that the controller was powered up without the driveline cable connected, likely in preparation for a controller exchange.The vad disconnect alarm cleared at 13:17:17, indicating that the driveline cable was connected to the controller.However, this was followed by a vad stopped alarm at 13:17:38 due to a failure of the pump to restart after several attempts.An additional controller power up event, followed by a vad stopped alarm due to a failure of the pump to restart, and vad disconnect alarm were subsequently logged, likely during troubleshooting and/or a controller exchange.As a result, the reported loss of power, vad stopped alarm, and power disconnect alarm events were confirmed.A possible root cause of the reported power disconnect alarm may be attributed, but not limited, to a physical disconnection of the power source.The most likely root cause of the initial loss of power to a different controller can be attributed to the reported disconnection of the one attached power source from the controller.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.Capa pr00502194 is investigating pump failures to restart.Additional products: d4: (b)(6) h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: device code(s): a141204, a0708 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10, d11 d4: (b)(6) h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: device code(s): a0708 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d4: (b)(6) h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: device code(s): a0708 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.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 information, investigation completion, and correction.Correction b5: event description was corrected to include a statement regarding the disposition of the ventricular assist device (vad).Correction h10: section h10 was corrected to include device and code information for the vad associated with the event.Additional information was received regarding the recall number.Product event summary: the pump, three (3) controllers ((b)(6)), and one (1) battery were not returned for evaluation.Review of the controller log files associated with (b)(6) revealed that a controller power up event was logged on (b)(6) 2020 at 12:27:09.Review of the event log file revealed that, prior to the power up event, the controller last had power on (b)(6) 2019, indicating that the controller was likely the patient¿s backup controller.A vad disconnect alarm was logged following the controller power up at 12:27:16, indicating that the controller was powered up without the driveline cable connected.Log file analysis revealed that (b)(6) was the patient's primary controller.Review of the controller log files associated with (b)(6) revealed controller power up events on (b)(6) 2020 at 13:01:28 and 13:01:57.The data point prior to the losses of power revealed that (b)(6) was connected to power port one (1) with 34% relative state of charge (rsoc) and no power source was connected to power port two (2).The data point recorded after the losses of power revealed that one battery was connected to power port one (1) and another battery was connected to power port two (2).No anomalies were observed leading up to the loss of power.The controller was without power for a maximum of 43 seconds.A vad stopped alarm was then logged at 13:02:36 due to a failure of the pump to restart after several attempts.This was followed by several additional controller power up events and vad disconnect alarms, indicating physical disconnections of the driveline from the controller, logged between 13:02:49 and 13:13:11, likely due to troubleshooting.Multiple additional vad stopped alarms were logged during this period, indicating that, on each occasion, the pump failed to restart after multiple attempts.Additionally, a power disconnect alarm was logged on (b)(6) 2020 at 13:14:50 involving (b)(6).During the power disconnect alarm, a safety alert word (saw) value was recorded indicating an overcurrent alert.The event log recorded a high-power consumption during the attempted motor starts, which required more current from the batteries.The battery was most likely physically disconnected by the patient shortly after, causing the controller to log this event as a power disconnect alarm.Log file analysis revealed that a controller exchange was then performed, after which (b)(6) was in use.A controller power up event was logged on (b)(6) 2020 at 13:17:00.A vad disconnect alarm was logged following the controller power up, at 13:17:07, indicating that the controller was powered up without the driveline cable connected, likely in preparation for a controller exchange.The vad disconnect alarm cleared at 13:17:17, indicating that the driveline cable was connected to the controller.However, this was followed by a vad stopped alarm at 13:17:38 due to a failure of the pump to restart after several attempts.An additional controller power up event, followed by a vad stopped alarm due to a failure of the pump to restart, and vad disconnect alarm were subsequently logged, likely during troubleshooting and/or a controller exchange.As a result, the reported loss of power, vad stopped alarm, and power disconnect alarm events were confirmed.A possible root cause of the reported power disconnect alarm may be attributed, but not limited, to a physical disconnection of the power source.The most likely root cause of the initial loss of power to (b)(6) can be attributed to the reported disconnection of the one attached power source from the controller.The most likely root cause of the vad stopped alarms can be attributed to failure of the pump to restart after several attempts.Capa pr00502194 is investigating pump failures to restart.Additional products: d1: heartware ventricular assist system ¿ pump d4: model #: 1103 / catalog #: 1103 / expiration date: 31-may-2020 / serial #: (b)(6) udi #: (b)(4) d9: no h3: yes h4: mfg date: 29-may-2018 h5: yes h6: patient ime code(s): e2403 h6: imf code(s): f26 h6: fda device code(s): a141204 h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 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 the vad remained in use.
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Manufacturer Narrative
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A supplemental report is being submitted as a new internal investigation has been assigned to this event.Also, updated section h6.Section h6 update for additional device: serial# (b)(6) h6: img code(s): g02002 serial# (b)(6) h6:fda img code: g04105 h6:fda result code(s):c21 h6:fda conclusion code(s): d16 serial# (b)(6) h6: img code(s): g04035 serial# (b)(6) h6: img code(s): g04035 the ventricular assist device (vad) (b)(6) is not in scope of capa pr00502194.Capa pr00532915 was initiated to investigate pump failures to restart outside the subpopulation of capa pr00502194.Investigation is pending.A report will be sent when root cause for the internal investigation has been determined.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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