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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSIST) BYPASS
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| Model Number 1420 |
| Device Problems
Device Inoperable (1663); Power Problem (3010)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 03/14/2018 |
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Event Type
malfunction
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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.Other devices involved in this event: heartware ventricular assist system ¿ battery/(b)(4) / model #: 1650de / expiration date: 2015-12-31, return date: 2018-03-30 , device evaluation anticipated, but not yet begun mfg date: 2014-12-31 (b)(4).Heartware ventricular assist system ¿ battery /(b)(4) / model #: 1650de / expiration date: 2017-04-30, return date: 2018-03-30 , device evaluation anticipated, but not yet begun mfg date: 2016-04-30 (b)(4).Heartware ventricular assist system ¿ battery/(b)(4) / model #: 1650de / expiration date: 2016-01-31, return date: 2018-03-30, device evaluation anticipated, but not yet begun mfg date: 2015-01-31(b)(4).Heartware ventricular assist system ¿ battery/(b)(4)/ model #: 1650de / expiration date: 2017-03-31, return date: 2018-03-30, device evaluation anticipated, but not yet begun mfg date: 2016-03-31.(b)(4).Heartware ventricular assist system ¿ battery/ (b)(4)/ model #: 1650de / expiration date: 2017-04-30, return date: 2018-03-30, device evaluation anticipated, but not yet begun mfg date: 2016-04-30 (b)(4).Heartware ventricular assist system ¿ battery/(b)(4)/ model #: 1650de, return date: 2018-03-30, device evaluation anticipated, but not yet begun (b)(4).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 there was power switching with the controller and six batteries.It was noted that there was an alarm beep when the battery was connected to the controller.It was noted that it was as though the battery was disconnecting then reconnecting quite quickly, apart from the one instance when all power was lost.The controller and batteries were exchanged.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The controller and batteries (bat203510, bat217877, bat204336, bat216522, bat216832, bat360203) were returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned controller and batteries revealed that the devices passed visual examination and functional testing.An attempt was made to replicate the issue by manipulating the batteries' connection to the controller during the analysis of the units.Results revealed that the electrical connections between the batteries and the controller were stable.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log files revealed several premature power-switching events that were due to momentary disconnections involving bat203510, bat217877, bat204336, bat216522, bat216832 and bat360203.Log file analysis re vealed one controller power up and motor starts on (b)(6) 2018 at 21:38:05 close to the event date.Several momentary disconnections were observed leading up to the loss of power.Momentary disconnection will result in an audible tone or "beep".This finding may be related to the loss of power.As a result, the reported power switching and loss of power events were confirmed.Additionally, log file analysis revealed that the batteries discharged as expected when in use.No vad stopped alarms were observed during the analyzed period.As a result, the reported power consumption issue and vad stopped alarms could not be confirmed.Based on the available information, the most likely root cause of the reported premature power switching events and "reported beeps" can be attributed to momentary disconnections between the controller and batteries.The most likely root cause of the reported loss of power can be attributed to a disconnection of both power sources from the controller and/or to an intermittent disconnection on one or both power sources.An internal investigation evaluated momentary disconnections.An internal investigation was initiated to capture events involving the controller losing power.Additional products: catalog #: 1650de, serial #: (b)(4), device evaluated by mfr: yes dev rtn to mfr? yes.Fda method code(s): 4112.Fda conclusion code(s): 12.Catalog #: 1650de, serial #: (b)(4), device evaluated by mfr: yes dev rtn to mfr? yes.Fda method code(s): 4112.Fda conclusion code(s): 12.Catalog #: 1650de, serial #: (b)(4), device evaluated by mfr: yes dev rtn to mfr? yes.Fda method code(s): 4112.Fda conclusion code(s): 12.Catalog #: 1650de, serial #: (b)(4), device evaluated by mfr: yes dev rtn to mfr? yes.Fda method code(s): 4112.Fda conclusion code(s): 12.Catalog #: 1650de, serial #: (b)(4), device evaluated by mfr: yes dev rtn to mfr? yes.Fda method code(s): 4112.Fda conclusion code(s): 12.Catalog #: 1650de, serial #: (b)(4), device available for mfr: yes dev rtn to mfr? yes.Fda method code(s): 4112.Fda conclusion code(s): 12.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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Product event summary: the controller ((b)(4)) and batteries ((b)(4)) were returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned controller and batteries revealed that the devices passed visual examination and functional testing.An attempt was made to replicate the issue by manipulating the batteries' connection to the controller during the analysis of the units.Results revealed that the electrical connections between the batteries and the controller were stable.Log file analysis revealed that the controller, (b)(4), contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log files revealed several premature power-switching events that were due to momentary disconnections involving (b)(4), confirming the reported event.Log file analysis revealed one controller power up and motor starts on 03/14/2018 at 21:38:05 close to the event date.The power sources attached before the loss of power, which was recorded at 21:37:56, were (b)(4)on power port 1 with 52% relative state of charge (rsoc) and (b)(4) on power port 2 with 93% rsoc.The power sources attached after the loss of power were (b)(4)on power port 1 with 52 relative state of charge (rsoc) and (b)(4) on power port 2 with 93% rsoc.Several momentary disconnections were observed leading up to the loss of power.This finding may be related to the loss of power.Based on the available information, the most likely root cause of the reported premature power switching events can be attributed to momentary disconnections between the controller and batteries.The most likely root cause of the reported loss of power can be attributed to a disconnection both power sources from the controller or due to momentary disconnection between the controller and batteries.Additional products: battery / (b)(4), h6 fda method code(s): 3372, battery / (b)(4), h6 fda method code(s): 3372, battery / (b)(4), h6 fda method code(s): 3372, battery / (b)(4), h6 fda method code(s): 3372.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 patient had issues with irregular battery charge and use and pump stop alarms.
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Manufacturer Narrative
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This supplemental is based solely on the receipt of a maude report.Section f has been updated to reflect that report.F1: user facility.F2 uf/importer report number: (b)(4).F3: user facility name/address: unknown.F4: contact person: unknown.F5: phone number unknown.F6: date user facility became aware of the event: (b)(6) 2018.F7: type of report: unknown.F8: date of this report: 07-aug-2018.F9: approximate age of device: 2 yr.F10: event problem codes: unknown.F12: location where event occurred: home.F13: report sent to manufacturer: unknown.F14: manufacturer name and address: mfr.Name: medtronic address: 8200 coral sea street ne city: mounds view state: mn zip: 55112.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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Product event summary, (b)(4): the returned controller passed visual inspection, functional checks and system running test.Investigation is ongoing.Additional products: battery/ (b)(4).H3: yes h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 product event summary: the returned battery passed visual inspection and functional testing.Investigation is ongoing.Battery/ (b)(4).H3: yes h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 product event summary: the returned battery passed visual inspection and functional testing.Investigation is ongoing.Battery/ (b)(4).H3: yes h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 product event summary: the returned battery passed visual inspection and functional testing.Investigation is ongoing.Battery/ (b)(4).H3: yes h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 product event summary: the returned battery passed visual inspection and functional testing.Investigation is ongoing.Battery/ (b)(4).H3: yes h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 product event summary: the returned battery passed visual inspection and functional testing.Investigation is ongoing.Battery/ (b)(4).H3: yes h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 product event summary: the returned battery passed visual inspection and functional testing.Investigation is ongoing.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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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