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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSIST) BYPASS
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| Model Number 1104 |
| Device Problems
Electrical /Electronic Property Problem (1198); Failure to Pump (1502); Pumping Stopped (1503)
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| Patient Problem
Heart Failure (2206)
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| Event Date 07/04/2020 |
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Event Type
Injury
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Manufacturer Narrative
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This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0.Model #: 1420, catalog #: 1420, expiration date: 31-aug-2019, 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: 06-aug-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 ventricular assist device (vad) stopped and was unable to be restarted.It was reported that there was suspected electrical damage and a review of data log files showed an apparent double power disconnection from the controller.The patient experienced worsening heart failure and was admitted to the intensive care unit (icu) and required administration of adrenaline.The vad remains out of service and 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 analysis and investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.Two (2) controllers (b)(6) and two (2) batteries (b)(6) were returned for evaluation.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) revealed that the batteries passed visual inspection.Functional testing revealed abnormalities related to the relative state of charge (rsoc); the batteries did not estimate the capacity accurately.This is an additional observation not related to the reported event, which can be attributed to an estimation error.Failure analysis of (b)(6) revealed that the controller passed visual inspection and functional testing.Failure analysis of (b)(6) revealed that the controller passed functional testing.Visual inspection revealed contamination within power port two of the controller.This is an additional finding not related to the reported event, likely due to the handling of the device.The controller performed as expected and no damage was observed.As a result, the reported controller damage event was not confirmed.Log file analysis revealed that (b)(6) was the patient's primary controller.Analysis of the event log file associated with (b)(6) revealed a controller power up event logged on (b)(6)2020 at 19:16:10.The data point prior to the loss of power revealed that (b)(6) was connected to power port one with 24% relative state of charge (rsoc) and a power adapter was connected to power port two.The data point recorded after the loss of power revealed that (b)(6) was connected to power port one and a power adapter was connected to power port two.No anomalies were recorded leading up to the loss of power.The controller was without power for 16 seconds.Analysis of (b)(6) alarm log file revealed two (2) vad stop alarms were logged on (b)(6)2020 at 19:16:37 and 19:20:12, due to a failure of the pump to restart after several attempts.Additionally, two (2) additional controller power up event an vad disconnect alarm were logged starting at 19:17:37, likely due to troubleshooting and/or controller exchange from (b)(6).Analysis of controller log files associated with (b)(6) revealed two (2) controller power up event logged on (b)(6)2020 at 19:23:48 and 19:24:37 and a vad disconnect alarm logged at 19:23:54.Review of the event log file revealed that, prior to the first power up event, the controller last had power on (b)(6)2019.Additionally, review of the data log file revealed that the controller (b)(4) was not in use prior to the first controller power up event; no data points had been logged since (b)(6)2019 and the first data point logged on (b)(6)2020, at 19:24:22, indicating that the power up events and vad disconnect alarm occurred during the controller exchange from (b)(6).This was followed by a vad stopped alarm was logged at 19:24:52 due to a failure of the pump to restart after several attempts.An additional vad disconnect alarm was logged at 19:26:13, likely due to troubleshooting and/or a controller exchange.As a result, the reported loss of power, vad stopped and failure to restart events were confirmed; however, the reported pump damaged event could not be confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.A possible root cause of the vad stopped alarms can be attributed to a failure of the pump to restart after several attempts.Based on historical review of similar events, the likely contributing cause of the failure of the pump to restart after several attempts was the inability of the pump-start algorithm to provide sufficient torque to overcome abnormally high mechanical re sistance caused by unknown conditions that existed prior to the failed restart attempt.Additional products: controller 2.0 d10: yes, return date: (b)(6)2020 h3: yes dev rtn to mfr? yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 331, 213 h6: fda conclusion code(s): 19, 4310, 22, 4315 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2019 / serial#: (b)(6) udi #: (b)(4) d10: yes, return date: 03-aug-2020 h3: yes dev rtn to mfr? yes h4: mfg date: 03-aug-2018 h5: no h6: patient code(s): c50577 h6: device code(s): c63025 h6: fda method code(s): 10, 4112 h6: fda results code(s): 213 h6: fda conclusion code(s): 4310 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-jul-2019 / serial#: (b)(6) udi #: (b)(4) d10: yes, return date: 02-sep-2020 h3: yes dev rtn to mfr? yes h4: mfg date: 22-jul-2018 h5: no h6: patient code(s): c50577 h6: device code(s): c63030 h6: fda method code(s): 10, 4112 h6: fda results code(s): 104 h6: fda conclusion code(s): 4307 d1: heartware ventricular assist system ¿ battery d4: model #: 1650de / catalog #: 1650de / expiration date: 31-jul-2019 / serial#: (b)(6) udi #: (b)(4) d10: yes, return date: 02-sep-2020 h3: yes dev rtn to mfr? yes h4: mfg date: 21-jul-2018 h5: no h6: patient code(s): c50577 h6: device code(s): c63030 h6: fda method code(s): 10, 4112 h6: fda results code(s): 104 h6: fda conclusion code(s): 4307 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 controller was removed from use.The back up controller and two batteries were returned to the manufacturer due to the associated event and tested out of specification.
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Event Description
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It was further reported that the ventricular assist device (vad) was decommissioned due to the patient having partial cardiac recovery.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Newly received information included some patient information and the status of the vad.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.Additional information was received regarding the recall number.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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