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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); Power Problem (3010)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 02/14/2018 |
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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 #: 1650 / expiration date: 2017-07-31 udi #:(b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun mfg date: 2016-07-31.(b)(4).Heartware ventricular assist system -battery/ (b)(4)/ model #: 1650 / expiration date: 2017-07-31 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun mfg date: 2016-07-31 (b)(4).Heartware ventricular assist system -battery/ (b)(4)/ model #: 1650 / expiration date: 2017-07-31 udi #:(b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun mfg date: 2016-07-31 (b)(4).Heartware ventricular assist system - battery / (b)(4)/ model #: 1650 / expiration date: 2017-07-31 udi #: (b)(4), return date: (b)(6) 2018, device evaluation anticipated, but not yet begun mfg date: 2016-07-31 (b)(4).
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Event Description
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It was reported that the controller and batteries exhibited power switching despite battery capacity greater than twenty-five percent (25%).During an exchange of batteries, there was an interruption of the power supply to the controller, an acoustic alarm sounded, and the controller completely shut down even though one battery after the other was changed.After the complete exchange, the controller came back on.The ventricular assist device (vad) stopped during this brief period.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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(b)(4) product event summary:the controller passed visual inspection and functional testing.However, the reported event was confirmed via log file review.Log files analysis revealed: 1 controller power-up and associated pump start event was logged on (b)(6) 2018 at 09:22:15.Qa data logs entry point to the controller power up event, at 09:21:17, revealed that (b)(4) was connected to power port 1 with 70% relative state of charge (rsoc) and (b)(4) was connected to power port 2 with 89% rsoc.The data point after the controller power up event, at 09:22:51, revealed that (b)(4) was connected to power port 1 with 97% rsoc and (b)(4) was connected to power port 2 with 89% rsoc.The pump was stopped for 17 seconds.Analysis of the data log files revealed several premature power switching events that were due to momentary disconnections involving: (b)(4).As a result, the reported event was confirmed.Additional products: battery / (b)(4), expiration date: 2017-07-31, udi #: (b)(4), device available for evaluation: yes, return date: 2018-02-23, device evaluated by mfr: yes, mfg date: 2016-07-31, labeled for single use: no.Product event summary:the returned battery passed external visual inspection and functional testing.However, the reported event was confirmed via log file review.Analysis of the data log files revealed several premature power switching events that were due to momentary disconnections.As a result, the reported event was confirmed.Additional products: battery / (b)(4), expiration date: 2017-07-31, udi #: (b)(4), device available for evaluation: yes, return date: 2018-02-23, device evaluated by mfr: yes, mfg date: 2016-07-31, labeled for single use: no.Product event summary:the returned battery passed external visual inspection and functional testing.However, the reported event was confirmed via log file review.Analysis of the data log files revealed several premature power switching events that were due to momentary disconnections.As a result, the reported event was confirmed.Additional products: battery / (b)(4), expiration date: 2017-07-31, udi #: (b)(4), device available for evaluation: yes, return date: 2018-02-23, device evaluated by mfr: yes, mfg date: 2016-07-31, labeled for single use: no, product event summary:the returned battery passed external visual inspection and functional testing.Log file analysis did not reveal any premature power switching event on the analyzed period.Additional products: battery / (b)(4), expiration date: 2017-07-31, udi #: (b)(4), device available for evaluation: yes, return date: 2018-02-23, device evaluated by mfr: yes, mfg date: 2016-07-31, labeled for single use: no, product event summary:the returned battery passed external visual inspection and functional testing.However, the reported event was confirmed via log file review.Analysis of the data log files revealed several premature power switching events that were due to momentary disconnections.As a result, the reported event was confirmed.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 and four (4) 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.Failure analysis of the returned devices revealed that the controller and batteries passed visual inspection and functional testing.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 data files revealed power switching events due to momentary disconnections involving (b)(4).Log file analysis also revealed a controller power up event was logged on 14/feb/2018 at 09:22:15.The qadata point prior to the loss of power revealed that (b)(4) was connected to power port one (1) with 70% relative state of charge ((b)(4)) and (b)(4) was connected to power port two (2) with 89% rsoc.Several momentary disconnections were recorded leading up to the loss of power involving (b)(4).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 13 seconds.Loss of power to the controller will result in a loud, continuous alarm, which corresponds with the reported ¿acoustic alarm¿ heard.As a result, the reported events were confirmed.The most likely root cause of the reported premature power switching events can be attributed to momentary disconnections between the controller and the 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.An internal investigation was initiated to capture events involving the controller losing power.An internal investigation evaluated momentary disconnections.Additional products: d4: model #: 1650de, catalog #: 1650de, serial #: (b)(4), h3: yes, dev rtn to mfr? yes, h6: fda method code(s): 10, 4112; h6: fda results code(s): 3213, h6: fda conclusion code(s): 12; d4: model #: 1650de, catalog #: 1650de, serial #: (b)(4), h3: yes, dev rtn to mfr? yes h6: fda method code(s): 10, 4112 h6: fda results code(s): 3213 h6: fda conclusion code(s): 12, d4: model #: 1650de, catalog #: 1650de, serial #: (b)(4), h3: yes, dev rtn to mfr? yes, h6: fda method code(s): 10, 4112; h6: fda conclusion code(s): 67; d4: model #: 1650de / catalog #: 1650de / serial #: (b)(4), h3: yes, dev rtn to mfr? yes, h6: fda method code(s): 10, 4112, h6: fda results code(s): 3213, h6: fda conclusion code(s): 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.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: it was reported that the controller and batteries exhibited power switching.During an exchange of batteries, there was an interruption of the power supply to the controller, an acoustic alarm sounded, and the controller completely shut down even though one battery after the other was changed.The controller (b)(4) and four 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.Failure analysis of the returned devices revealed that the controller and batteries passed visual inspection and functional testing.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 data files revealed power switching events due to momentary disconnections involving (b)(4).Log file analysis revealed a controller power up and motor start event on (b)(6) 2018 at 09:22:15 and 09:22:19 respectively.The data point prior t o the loss of power revealed that (b)(4)was connected to power port 1 with 70% relative state of charge (rsoc) and (b)(4) was connected to power port 2 with 89% rsoc.The data point after the loss of power revealed that (b)(4) was connected to power port 1 with 97% rsoc and (b)(4) was connected to power port 2 with 89% rsoc.Controller 2.0 has a feature that captures the date and time when the controller loss power.The pump off time was 17 seconds.As a result, the reported events were confirmed.The most likely root cause of the reported power switching can be attributed to momentary disconnections between the controller and the batteries.Capa00350 is investigating momentary disconnections.A possible root cause of the loss of power can be attributed to a disconnection of both power sources, given that one power source connected prior the loss of power was replaced.Capa pr375800 is investigating double disconnections.Additional products: d4: battery / (b)(4).Expiration date: 2017-07-31 udi #: (b)(4).D10: yes, return date: 2018-02-23 h3: yes h4: mfg date: 2016-07-31 h6 fda results code(s): 213 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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