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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1102 |
| Device Problem
Failure to Pump (1502)
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| Patient Problems
Loss of consciousness (2418); Insufficient Information (4580)
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| Event Date 07/14/2021 |
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Event Type
Death
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Manufacturer Narrative
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Additional information has been requested regarding the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.Additional products: heartware ventricular assist system unk controller, model #: unk / catalog #: unk / expiration date: unk / serial or lot#: unk, udi #: (b)(4), device available for evaluation: no, device manufacture date: unk, labeled for single use: no.(b)(4).Heartware ventricular assist system unk controller, model #: unk / catalog #: unk / expiration date: unk / serial or lot#: unk, udi #: (b)(4), device available for evaluation: no,device manufacture date: unk, labeled for single use: no.(b)(4).Heartware ventricular assist system unk controller, model #: unk / catalog #: unk / expiration date: unk / serial or lot#: unk, udi #: (b)(4) , device available for evaluation: no.Device manufacture date: unk, 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 at home and the controller was alarming.A controller exchange was performed by the patient's spouse and the ventricular assist device (vad) did not restart.The vad coordinator instructed the patient's spouse to perform another controller exchange.The controller was exchanged three times with three different controllers in an attempt to restart the vad but the vad did not restart.The patient was then sent to the local hospital as they had lost consciousness and subsequently expired.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Additional information received with the initial reports controllers serial numbers and three additional controller serial numbers, all serial numbers and the manufacturing date and use before date, unique device identifier and codes have been updated.Additional products: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-dec-2018 / serial #: (b)(6) udi #: (b)(4) h4: mfg date: 21-dec-2017 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2022 / serial #: (b)(6) udi #: (b)(4) h4: mfg date: 08-jan-2021 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2022 / serial #: (b)(6) udi #: (b)(4) h4: mfg date: 08-jan-2021 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420/ expiration date: 31-dec-2018 / serial #: (b)(6) udi #: (b)(4) d9: no h4: mfg date: 29-dec-2017 h5: no h6: patient ime code(s): e2401 h6: imf code(s): f02, f2301 h6: img code(s): g04035 h6: fda device code(s): a141204 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420/ expiration date: 30-sep-2018 / serial #: (b)(6) udi #: (b)(6) d9: no h4: mfg date: 30-sep-2017 h5: no h6: patient ime code(s): e2401 h6: imf code(s): f02, f2301 h6: img code(s): g04035 h6: fda device code(s): a141204 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420/ expiration date: 31-may-2017 / serial #: (b)(6) udi #: (b)(4) d9: no h4: mfg date: 31-may-2016 h5: no h6: patient ime code(s): e2401 h6: imf code(s): f02, f2301 h6: img code(s): g04035 h6: fda device code(s): a141204 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 investigation of this event is pending and a supplemental report will be sent upon its completion.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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A supplemental report is being submitted for device evaluation and investigation completion and additional information.The additional information is from the additional device that was return and tested out of specification.The event description and the additional device (battery) was updated in h10.Product event summary: the pump (b)(6) was not returned for evaluation.The six (6) controllers (b)(6) and the battery (b)(6), were returned for evaluation.No performance allegations were made against the battery.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 (b)(6) revealed that the device passed visual inspection.Functional testing of (b)(6) revealed an abnormal voltage plot regarding cell pair two of the battery; despite this finding, the battery was still able to charge and provide power.Internal inspection did not reveal any anomalies.It was noted that the battery had a cycle count of 137 and that there was a time difference of 1847 days between the manufacturing date and the reported event date.This indicates that the battery was most likely not in use for an extended period of time.Hence, the battery was susceptible to an expected degradation of capacity as a result of non-usage.The observed degraded cell pair is an additional finding not related to the reported event.The most likely root cause of the observed degraded cell pair can be attributed to an expected degradation as a result of non-usage over time.Failure analysis of (b)(6) revealed that the controllers passed visual inspection and functional testing.Log file analysis associated with (b)(6) revealed that the controllers were not used on the reported event date.Failure analysis of (b)(6) revealed that the controllers passed visual inspection.Functional testing of (b)(6) revealed that the controllers front panel light emitter diode (led) indicators did not illuminate while connected to batteries.Functional testing also revealed that the controllers were unable to communicate with external batteries, resulting in critical battery alarms; however, the controllers were still able to receive power from both power sources.Internal inspection of (b)(6) revealed damaged diodes on the communication line and damaged integrated circuits, responsible for the communication between the controllers and batteries.The damaged integrated circuits are connected to the user interface controllers (uics) responsible for the operations of the controllers; the damaged integrated circuits prevented the controllers from reading battery information and caused the controllers to trigger the critical battery alarms, as well as the controller reset events.The damaged integrated circuits are also connected to the real time clock circuits and caused the date/time stamps to remain frozen.After the faulty components were replaced, the controllers performed as intended.Review of the data log files associated with (b)(6) revealed data points logged with a battery relative state of charge (rsoc) value of 101% or no battery capacity and with an incorrect date stamp, no serial number id, and no cycle count, indicating that the controllers were unable to recognize the connected batteries.Review of the alarm log files associated with (b)(6) did not reveal any vad stopped alarms logged within the analyzed period.Analysis of the alarm log files associated with (b)(6) revealed multiple critical battery alarms logged with battery relative state of charge (rsoc) values of 101% or no battery capacity and with an incorrect date stamp, no serial number id, and no cycle count, indicating that the controllers were unable to recognize the connected batteries.In addition, log files associated with (b)(6) revealed multiple controller reset events with an incorrect date and time stamp.Log file analysis associated with (b)(6) revealed a controller power up event with an associated motor start with an incorrect date stamp.Additionally, log file analysis associated (b)(6) revealed controller power up events without motor start events and vad disconnect alarms indicating a physical disconnection of the driveline from the controllers, likely due to troubleshooting of the controllers and/or controller exchanges.Review of the controllers log files did not reveal any alarms or data points logged on the reported event date.Log file analysis for the controllers in use during the reported event date were not available for analysis.As a result, the reported initial alarm on the primary controller in use during the reported event could not be confirmed due to insufficient information.The reported failure to restart event could not be confirmed.The most likely root cause of the observed display error, inability of the controllers to recognize the batteries, critical battery alarms, controller resets, and real time clock issue events can be attributed to damaged diodes and damaged integrated circuits.A possible root cause for the damaged diodes and integrated circuits on the communication line can be attributed to voltage spikes on the communication pins of the connectors.Capa pr00465502 was opened to investigate this issue.Based on the available information, 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.Capa pr00551638 is investigating controller losses of power.An internal investigation was created to further investigate failures of the pump to restart.Additional products: d4: serial #: (b)(6) d10: yes, return date: 22-nov-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g04034 h6: fda method code(s): b01,b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 additional products: d4: serial #:con415028 d10: yes, return date: 22-nov-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g04034 h6: fda method code(s): b01,b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 additional products: d4: serial #: (b)(6) d10: yes, return date: 22-nov-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g04034 h6: fda method code(s): b01,b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 additional products: d4: serial #: (b)(6) d10: yes, return date: 22-nov-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g02013, g0201207 h6: fda method code(s): b01,b15 h6: fda results code(s): c02, c0205 h6: fda conclusion code(s): d11 additional products: d4: serial #: (b)(6) d10: yes, return date: 22-nov-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g02013, g0201207 h6: fda method code(s): b01,b15 h6: fda results code(s): c02, c0205 h6: fda conclusion code(s): d11 additional products: d4: serial #: (b)(6) d10: yes, return date: 22-nov-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g02013, g0201207 h6: fda method code(s): b01,b15 h6: fda results code(s): c02, c0205 h6: fda conclusion code(s): d11, d15 additional products: d1: heartware ventricular assist system ¿ battery d4: model #:1650de / catalog #: 1650de / expiration date: 31-dec-2016 / serial #: (b)(6) udi #: (b)(6) d9: yes, return date:22-nov-2022 h3: yes dev rtn to mfr? yes h4: mfg date: 31-dec-2015 h5: no h6: patient ime code(s): e0119, e2401 h6: imf code(s): f02, f2301 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b01, b15 h6: fda results code(s): c020701 h6: fda conclusion code(s): d02 investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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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The battery was returned to the manufacturer as an associated device to the controller.The battery subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental correction is being submitted for inclusion of this event as being in-scope for recall with z-0946-2021.This event was submitted historically and has been deemed in-scope for the field corrective action.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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