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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 Known Impact Or Consequence To Patient (2692)
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| Event Date 02/17/2018 |
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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.Concomitant medical products: d314vrg icd implanted: (b)(6) 2011, 693558 lead, implanted: (b)(6) 2018.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 which happened intermittently at random and even occasionally at night that would wake up the patient.It was noted that the patient identified one battery it seemed to occur on frequently.Log file review noted critical battery alarms on five batteries.In addition ,there were controller power-up and associated pump start events indicating a loss of power to the controller.The controller was exchanged, and the batteries 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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Aware date 2018-mar-01.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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It was further reported that the patient experienced power switching with the batteries, controller ac adapter and controller dc adapter.Servicing was performed on all power sources.The batteries, controller ac adapter and controller dc adapter remain in use.
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Manufacturer Narrative
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Corrections: d4, h10: d1, d4, d10, h3, h4, h5, h6 other devices involved in this event: d1: heartware ventricular assist system ¿ battery d4: battery / (b)(4) / model #: 1650de / expiration date: 2018-09-30 udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 2017-09-30 h5: no h6: device code(s): c63030 d1: heartware ventricular assist system ¿ battery d4: battery / (b)(4) / model #: 1650de / expiration date: 2018-12-31 udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 2017-12-31 h5: no h6: device code(s): c63030 d1: heartware ventricular assist system ¿ battery d4: battery / (b)(4) / model #: 1650 / expiration date: 2017-03-31 udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 2016-03-31 h5: no h6: device code(s): c63030 d1: heartware ventricular assist system ¿ battery d4: battery / (b)(4)/ model #: 1650 / expiration date: 2018-06-30 udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 2017-06-30 h5: no h6: device code(s): c63030 d1: heartware ventricular assist system ¿ battery d4: battery / (b)(4) / model #: 1650 / expiration date: 2018-06-30 udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 2017-06-30 h5: no h6: device code(s): c63030 d1: heartware ventricular assist system ¿ controller ac adapter d4: controller ac adapter / (b)(4) / model #: 1430us / expiration date: unknown udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unknown h5: no h6: device code(s): c63025 d1: heartware ventricular assist system ¿ controller dc adapter d4: controller dc adapter / (b)(4) / model #: 1440 / expiration date: unknown udi #: (b)(4).D10: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: unknown h5: no h6: device code(s): c63025 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: the controller (con314630) was returned for evaluation.Five batteries (bat586465, bat591740, bat320204, bat556397, bat556781), one controller ac adapter (cac101097), and one controller dc adapter (cdc201319) were not returned for evaluation.Various analyses were conducted in order to evaluate the performance of the devices in relation to the reported events.Failure analysis of the returned controller revealed that the device passed visual examination and functional testing.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 alarm log files revealed several critical battery alarms due to communication errors involving bat586465, bat591740, bat320204, bat556397, and bat556781 within the analyzed period.Analysis of data log files revealed several premature power switching events due to momentary disconnections involving bat586465, bat591740, bat320204, and bat556397, as well as premature power switching events due to communication errors involving bat586465 and bat556397.Log file analysis also revealed 23 controller power up events logged within the analyzed period.Several momentary disconnections were logged in the periods surrounding the loss of power events.As a result, the reported critical battery alarms, power switching, and loss of power events were confirmed.A power source lubrication procedure was performed on the power sources on june 26, 2018 to mitigate the reported conditions and the batteries and adapters remain in use.The most likely root cause of the reported power switching event can be attributed to communication errors and momentary disconnections between the controller and batteries.The most likely root cause of the reported critical battery alarm event can be attributed to communication errors between the controller and batteries.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.Additional products: battery / bat586465 h3: yes h6 fda method code(s): 4112, 4114 h6 fda results code(s): 3213 h6 fda conclusion code(s): 12, 4307 battery / bat591740 h3: yes h6 fda method code(s): 4112, 4114.Fda results code(s): 3213 h6 fda conclusion code(s): 12, 4307 battery / bat320204.Yes.Fda method code(s): 4112, 4114 h6 fda results code(s): 3213.Fda conclusion code(s): 12, 4307 battery / bat556397 h3: yes h6 fda method code(s): 4112, 4114.Fda results code(s): 3213 h6 fda conclusion code(s): 12, 4307 battery / bat556781 h3: yes.Fda method code(s): 4112, 4114 h6 fda results code(s): 3213 h6 fda conclusion code(s): 4307 controller ac adapter / cac101097 h3: yes h6 fda method code(s): 4112, 4114 h6 fda results code(s): 213 h6 fda conclusion code(s): 67 controller ac adapter / cdc201319 h3: yes h6 fda method code(s): 4112, 4114 h6 fda results code(s): 213 h6 fda conclusion code(s): 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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It was also reported that after routine log file review, an additional battery was indicated to have had a communication error.The battery remains in use.
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Manufacturer Narrative
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Product event summary: the controller (b)(6) was returned for evaluation.Six (6) batteries (b)(6), one (1) controller ac adapter (cac101097), and one (1) controller dc adapter (cdc201319) were not returned for evaluation.Various analyses were conducted in order to evaluate the performance of the returned controller in relation to the reported events.Failure analysis of the returned controller revealed that the device passed visual examination and functional testing.Log file analysis revealed that the controller, (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 alarm log files revealed several critical battery alarms recorded due to communication errors involving (b)(6).Analysis of the event log files revealed multiple controller power-up events within the analyzed period.Momentary disconnections were observed leading up to various losses of power.Analysis of the data log files revealed several premature power switching events due to momentary disconnections involving (b)(6) as well as premature power switching events due to communication errors involving (b)(6) within the analyzed period.In addition, data log files revealed several instances involving (b)(6) where the respective battery¿s relative state of charge (rsoc) was between 101-201, which is indicative of a communication error.As a result, the reported events were confirmed.There is no evidence that the lubrication servicing was performed on (b)(6).The most likely root cause of the reported critical battery alarms can be attributed to communication errors between the controller and batteries.The most likely root cause of the reported premature power switching events can be attributed to communication errors and momentary disconnections between the controller and batteries.The most likely root cause of the observed rsoc values between 101-201 can be attributed to communication errors.A possible root cause of the losses 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.An internal investigation evaluated momentary disconnections.Additional products: battery(b)(6) h6: fda conclusion code(s): 12 d1: heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: unk / serial or lot#: (b)(6).Udi #: (b)(4).D10: no h3: yes h4: mfg date: unk h5: no h6: patient code(s): c76143 h6: device code(s): c63030 h6: fda method code(s): 4112, 4114 h6: fda results code(s): 3213 h6: fda conclusion code(s): 4307, 12 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.If information is provided in the future, a supplemental report will be issued.
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