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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0; VENTRICULAR (ASSIST) BYPASS
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| Model Number 1407DE |
| Device Problems
Loose or Intermittent Connection (1371); Power Problem (3010)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 12/03/2017 |
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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 ¿controller 1.0 controller/ (b)(4)/ model #: 1407de/ expiration date: 2016-08-31, mfg date: 2015-08-31, (b)(4).Heartware ventricular assist system ¿battery: battery / (b)(4)/ model #: 1650de / expiration date: 2016-01-31 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun, mfg date: 2015-01-31, (b)(4).Heartware ventricular assist system ¿battery : battery /(b)(4)/ model #: 1650de / expiration date: 2016-01-31, udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun, mfg date: 2015-01-31, (b)(4).Heartware ventricular assist system ¿battery: battery / (b)(4)/ model #: 1650de / expiration date: 2015-09-30 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun, mfg date: 2014-09-30, (b)(4).Heartware ventricular assist system ¿battery : battery / (b)(4)/ model #: 1650de / expiration date: 2016-01-31 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun, mfg date: 2015-01-31, (b)(4).Heartware ventricular assist system ¿battery : battery / (b)(4)/ model #: 1650de / expiration date: 2018-05-31 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun mfg date: 2017-05-31, (b)(4).Heartware ventricular assist system ¿battery : battery / (b)(4)/ model #: 1650de / expiration date: 2016-01-31 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun, mfg date: 2015-01-31 (b)(4).
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Event Description
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It was reported that there was power switching and a loose power port on two controllers.There was also power switching on six batteries.One controller and six batteries were exchanged, and one controller will be exchanged.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 passed functional testing and visual inspection revealed that the controller power port one connector was loose from controller housing.The returned batteries passed visual inspection and functional testing.Investigation is ongoing.Additional products: (b)(4).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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Manufacturer Narrative
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Product event summary: two controllers (b)(4) and (b)(4) and six batteries (b)(4) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Review of the manufacturing documentation of (b)(4) and (b)(4) confirmed that the associated devices met all requirements for release.Failure analysis of the returned batteries revealed that the devices passed visual examination and functional testing.Failure analysis of the returned controllers (b)(4) and (b)(4) revealed that the devices passed functional testing.However, visual inspection revealed that the power port 1 connectors were loose on both controllers.As a result, the reported loose power port event was confirmed.The review of the log files from (b)(4) indicated that the device was likely the backup controller; the log files did not cover the reported event date.Log file analysis revealed that the controller in use during the reported event date, (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), (b)(4), (b)(4), and (b)(4) and premature power switching due to a communication error involving (b)(4).As a result, the reported power switching event was confirmed.Based on an internal investigation, the most likely root cause of the reported loose connector event can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.The most likely root cause of the reported power switching event can be attributed to momentary disconnections and communication errors between the controller and batteries.There is an internal investigation for momentary disconnections.Correction to g1, g2 and h6 fda codes: d4: controller / (b)(4).H6: device code: c63055, c63025 method code: fda 10 results code: fda 180 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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Manufacturer Narrative
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Product event summary: one controller (b)(4) and six batteries (b)(4) were returned for evaluation.One controller (b)(4) was not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Review of the manufacturing documentation of (b)(4) and (b)(4) confirmed that the associated devices met all requirements for release.Failure analysis of the returned batteries revealed that the devices passed visual examination and functional testing.Failure analysis of the returned controller (b)(4) revealed that the device passed functional testing; visual examination revealed a loose connector on power port 1.As a result, the reported "loose power port" event was confirmed in regards to (b)(4); however, the event could not be confirmed in regards to (b)(4) since the device was not returned for analysis.The review of the log files from (b)(4) indicated that the device was likely the backup controller; the log files did not cover the reported event date.Log file analysis revealed that the controller in use during the reported event date, (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) and premature power switching due to a communication error involving (b)(4).As a result, the reported power switching event was confirmed.Based on an internal investigation, the most likely root cause of the reported loose connector event can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.The most likely root cause of the reported power switching event can be attributed to momentary disconnections and communication errors between the controller and batteries.There is an internal investigation for momentary disconnections.Other devices in the event: d4: controller / (b)(4).H6: device code: c63055, c63025 method code: fda 4112, 4114, 3331 results code: fda 3213 conclusion code: fda 12, 4307 battery (b)(4), h6: device code: c63030 method code: fda 10, 4112 results code: fda 3213 conclusion code: fda 12 battery (b)(4).H6: device code: c63030 method code: fda 10, 4112 results code: fda 3213 conclusion code: fda 12 battery (b)(4).H6: device code: c63030 method code: fda 10, 4112 results code: fda 3213 conclusion code: fda 12 battery (b)(4).H6: device code: c63030 method code: fda 10, 4112 results code: fda 3213 conclusion code: fda 12 battery (b)(4).H6: device code: c63030 method code: fda 10, 4112 results code: fda 213 conclusion code: fda 67 battery (b)(4).H6: device code: c63030 method code: fda 10, 4112 results code: fda 3213 conclusion code: fda 4307 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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Manufacturer Narrative
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Corrections: b3, b5, e1, e3, g4, h10.Product event summary: two (2) controllers (b)(6) and six (6) batteries (b)(6) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Review of the manufacturing documentation of (b)(6) confirmed that the associated devices met all requirements for release.Failure analysis of the returned batteries revealed that the devices passed visual examination and functional testing.Failure analysis of the returned controllers (b)(6) revealed that the devices passed functional testing.However, visual inspection revealed that the power port 1 connectors were loose on both controllers.The review of the log files from (b)(6)indicated that the device was likely the backup controller; the log files did not cover the reported event date.Log file analysis revealed that the controller in use during the reported event date, (b)(6), 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)(6) and premature power switching due to a communication error involving (b)(6).Data log files also revealed a relative state of charge (rsoc) between 101-201 involving (b)(6), which is indicative of a communication error.As a result, the reported events were confirmed.Based on an internal investigation conducted, the most likely root cause of the reported loose connector event can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.The most likely root cause of the reported power switching event can be attributed to momentary disconnections and communication errors between the controller and batteries.Possible root causes of the reported 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.An internal investigation examined momentary disconnections.This event was assessed and is being reported as part of a retrospective review of log file data.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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Log file review indicated one battery also had a communication error.
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Search Alerts/Recalls
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