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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); Device Displays Incorrect Message (2591)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 06/16/2018 |
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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: battery/ (b)(4) / model #1650de / udi#: (b)(4).Device available for evaluation: no.Mfg.Date: 2017-05-31.Labeled for single use: no.(b)(4).Battery/ (b)(4) / model #1650de / udi#: (b)(4).Device available for evaluation: no.Mfg.Date: 2017-05-31.Labeled for single use: no.(b)(4).Battery/ (b)(4) / model #1650de / udi#: (b)(4).Device available for evaluation: no.Mfg.Date: 2017-05-31.Labeled for single use: no.(b)(4).Battery/ (b)(4) / model #1650de / udi#: (b)(4).Device available for evaluation: no.Mfg.Date: 2017-05-31.Labeled for single use: no.(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 the patient was experiencing multiple critical battery alarms that resolved after a few seconds.Critical battery alarms have been logged since (b)(6) 2018 on two batteries.There was controller power-up and associated pump start event was logged on the alleged controller indicating a loss of power to the controller.The controller and batteries were replaced.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the controller was returned for evaluation.Four (4) batteries have not been 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 under 10x magnification revealed hairline cracks around power port 2.An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.Based on an internal investigation, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Log file analysis revealed that the controller, contained a software with a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the alarm log file revealed eight (8) critical battery alarms due to communication errors involving (b)(4) and (b)(4) logged since (b)(6) 2018.Analysis of the event log file revealed one (1) controller power up event, with associated motor start event, on (b)(6) 2018 at 17:50:26, indicating a loss of power to the controller.The data point prior to the loss of power revealed that (b)(4) was connected to power port one (1) with 86% relative state of charge (rsoc) and (b)(4) was connected to power port two (2) with 23% rsoc.The data point recorded after the loss of power revealed that (b)(4) was connected to power port (1) and (b)(4) was connected to power port two (2).The controller was without power for 6 seconds.As a result, the reported critical battery alarm and controller loss of power events were 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.The most likely root cause of the critical battery alarms can be attributed to communication errors between the batteries and controller.An investigation was initiated to capture events involving the controller losing power.D4: battery/ (b)(4).H6: method code: fda 4112, fda 4114 results code: 3213 conclusion code: fda 4307 d4: battery/ (b)(4).H6: method code: fda 4112, fda 4114 results code: 213 conclusion code: fda 67 d4: battery/ (b)(4).H6: method code: fda 4112, fda 4114 results code: 3213 conclusion code: fda 4307 d4: battery/ (b)(4).H6: method code: fda 4112, fda 4114 results code: 213 conclusion code: fda 67 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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Log file review indicated that two of the batteries also had a communication error.
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Manufacturer Narrative
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Product event summary: the controller and four (4) batteries ((b)(4)) 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 the returned batteries (b)(4) revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned battery (b)(4) revealed that the device passed functional testing.Visual inspection revealed that the battery was received with the housing cracked open.This is an additional finding unrelated to the reported event.The most likely root cause of the cracked battery housing can be attributed to the handling of the device.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection under 10x magnification revealed hairline cracks around power port two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.Based on an internal investigation, the root cause of the hairline crack s was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Log file analysis revealed that the controller contained a software with a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the alarm log file revealed multiple critical battery alarms logged due to communication errors involving (b)(4) within the analyzed period.Data log files revealed multiple instances involving (b)(4) where the batteries¿ relative state of charge (rsoc) was between 101-201, which are indicative of communication errors.There is no evidence that the lubrication servicing was performed on the associated devices.Analysis of the event log file revealed one (1) controller power up event recorded on 21/jun/2018 at 17:50:26.The data point prior to the loss of power revealed that (b)(4) was connected to power port one (1) with 86% rsoc and (b)(4)was connected to power port two (2) with 23% rsoc.The data point recorded after the loss of power revealed that (b)(4) was connected to power port one (1) and (b)(4) was connected to power port two (2).The controller was without power for 6 seconds.As a result, the reported events were confirmed.The most likely root cause of the critical battery alarms can be attributed to communication errors between the controller and batteries.Possible root causes of the communication errors can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the battery, and/or due to the packet error checking method detecting bit errors.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.An internal investigation was initiated to capture events involving the controller losing power.This event was assessed and is being reported as part of a retrospective review of log file data.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: b3, b5 product event summary: the controller (con312071) and four (4) batteries (bat511869, bat511897, bat511891, bat511849) 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 the returned batteries bat511869, bat511897, and bat511891 revealed that the devices passed visual inspection and functional testing.Failure analysis of the returned battery bat511849 revealed that the device passed functional testing.Visual inspection revealed that the battery was received with the housing cracked open.This is an additional finding unrelated to the reported event.The most likely root cause of the cracked battery housing can be attributed to the handling of the device.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection under 10x magnification revealed hairline cracks around power port two (2).An internal inspection did not reveal evidence of fluid ingress.The observed hairline cracks are not related to the reported event.Based on an internal investigation, the root cause of the hairline cracks was determined to be due to chemical additives applied to the power port gaskets during the manufacturing process.The chemical additives contributed to environmental stress cracking.Log file analysis revealed that the controller, con312071, contained a software with a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the alarm log file revealed eight (8) critical battery alarms due to communication errors involving bat511869 and bat511891 logged since (b)(6) 2018.Analysis of the event log file revealed one (1) controller power up event recorded on (b)(6) 2018 at 17:50:26.The data point prior to the loss of power revealed that bat511891 was connected to power port one (1) with 86% relative state of charge (rsoc) and bat511849 was connected to power port two (2) with 23% rsoc.The data point recorded after the loss of power revealed that bat511869 was connected to power port one (1) and bat511891 was connected to power port two (2).The controller was without power for 6 seconds.As a result, the reported critical battery alarms and loss of power events were confirmed.The most likely root cause of the critical battery alarms can be attributed to communication errors between the controller and batteries.A possible root cause of the loss of power can be attr ibuted to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.There is an internal investigation for events involving the controller losing power.Additional products: d1: heartware ventricular assist system ¿ battery bat511869 d4: expiration date: 31-may-2018 d10: yes, return date: 2019-05-29 h3: yes dev rtn to mfr? yes h6: patient code(s): c50675 h6: fda method code(s): 10 d1: heartware ventricular assist system ¿ battery bat511897 d4: expiration date: 31-may-2018 d10: yes, return date: 2019-05-29 h3: yes dev rtn to mfr? yes h6: patient code(s): c50675 h6: fda method code(s): 10 d1: heartware ventricular assist system ¿ battery bat511891 d4: expiration date: 31-may-2018 d10: yes, return date: 2019-05-29 h3: yes dev rtn to mfr? yes h6: patient code(s): c50675 h6: fda method code(s): 10, 4112 d1: heartware ventricular assist system ¿ battery bat511849 d4: expiration date: 31-may-2018 d10: yes, return date: 2019-05-29 h3: yes dev rtn to mfr? yes h6: patient code(s): c50675 h6: fda method code(s): 10 h6: fda results code(s): 180 h6: fda conclusion code(s): 19 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 patient had multiple critical battery alarms on four batteries that resolved after a few seconds.Critical battery alarms have been logged since (b)(6)2018 on two batteries.There was controller power-up and associated pump start eventwas logged on the alleged controller indicating a loss of power to the controller.The controller and batteries were replaced.No patient complications have been reported as a result of this event.
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