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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number MCS1705PU |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503); Date/Time-Related Software Problem (2582); Battery Problem (2885); Connection Problem (2900); Power Problem (3010); Appropriate Term/Code Not Available (3191)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 07/13/2022 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2021 / serial or lot#: (b)(4), udi #: (b)(4), device avialable for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, mfg date: 26-aug-2020, labeled for single use: no, (b)(4).Brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-aug-2021 / serial or lot#: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, mfg date: 26-aug-2020, labeled for single use: no, (b)(4).Brand name: heartware ventricular assist system ¿ battery, model #: 1650 / catalog #: 1650 / expiration date: 31-mar-2021 / serial or lot#: (b)(4), udi #: (b)(4), device available for evaluation: no, device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun, mfg date: 25-mar-2020, labeled for single use: no, (b)(4).Additional information has been requested regarding the details of 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.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 one controller exhibited a real time clock error and was exchanged.After the exchange to a second controller, the ventricular assist device (vad) failed to restart and the second controller and vad were removed from service.It was also reported that a battery exhibited an erroneous critical battery alarm that was associated with a communication error that was shown in the logfiles.It was also reported that the battery had a defective port.The battery was removed from service.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted for patient relevant history and additional event details.Additional information has been requested regarding the allegations against four of the devices in this 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: d1: heartware ventricular assist system ¿ controller 2.0 d4: model#: 1420 / catalog#: 1420 / expiration date: 31-dec-2022 / serial#: (b)(6) udi#: (b)(4) d9: yes, return date: 16-aug-2022 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 20-dec-2021 h5: no h6: patient ime code(s): e2403 h6: imf code(s): f08, f0801, f2203 h6: img code(s): g04035 h6: fda device code(s): a0708 h6: fda method code(s): b21 h6: fda results code(s): c16 h6: fda conclusion code(s): d21 d1: heartware ventricular assist system ¿ battery d4: model#: 1650de / catalog#: 1650de / expiration date: 31-mar-2021 / serial#: (b)(6) udi#: (b)(4) d9: yes, return date: 16-aug-2022 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 25-mar-2020 h5: no h6: patient ime code(s): e2403 h6: imf code(s): f08, f0801, f2203 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c16 h6: fda conclusion code(s): d21 d1: heartware ventricular assist system ¿ battery d4: model#: 1650de / catalog#: 1650de / expiration date: 31-mar-2021 / serial#: (b)(6) udi#: (b)(4) d9: yes, return date: 16-aug-2022 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 25-mar-2020 h5: no h6: patient ime code(s): e2403 h6: imf code(s): f08, f0801, f2203 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c16 h6: fda conclusion code(s): d21 d1: heartware ventricular assist system ¿ battery d4: model#: 1650de / catalog#: 1650de / expiration date: 31-mar-2021 / serial#: (b)(6) udi#: (b)(4) d9: yes, return date: 16-aug-2022 h3: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes h4: mfg date: 25-mar-2020 h5: no h6: patient ime code(s): e2403 h6: imf code(s): f08, f0801, f2203 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c16 h6: fda conclusion code(s): d21 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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Event Description
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It was further reported that an additional controller and three batteries were related to this event.
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Manufacturer Narrative
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Additional products: d1: controller d4: serial#: (b)(6) h6: imf code(s): f0801, f2203 h6: fda device code(s): a12, a708 d1: controller d4: serial#: (b)(6).H6: imf code(s): f0801, f2203 d1: battery d4: serial#: (b)(6) h6: imf code(s): f0801, f2203 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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Event Description
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It was further reported that the patient¿s spouse called the emergency hotline stating that various unknown alarms occurred alternately on the patient¿s ventricular assist device (vad).The alarms were heard in the background as alternating low and high priority alarms.The patient¿s spouse was asked, what the message on the controller display was to which they replied that ¿it was too dark and could not read anything¿.However, the patient spouse was able to confirm that the low priority alarms were "power disconnect alarms¿ because there was no power source connected to one power port of the controller.Of note, another power source was connected and was not recognized.The spouse was then told to connect a power source anyway.This was done, but it took quite a while due to the spouse becoming visibly overwhelmed with the situation and could hardly follow instructions as well as the nomenclature used.Accor ding to the spouse, an unknown power source was then also recognized.The spouse could not give any information about the high-priority alarm, as it went silent again too quickly.The alarm could also be heard sounding sporadically and assumed it was a "critical battery" alarm or a temporary vad stop.The spouse was told to immediately contact the attending clinic and to go quickly with the pa tient via ambulance.The patient¿s spouse was then told to have the clinic contact the clinical specialist immediately and if possible, not to take any action on the system without instruction; being that the situation was deemed potentially critical.Several atte mpts were made to contact the clinic without success along with the patient¿s spouse.Approximately one and a half hour later the clinic called, and a continuous high priority alarm was heard in the background along with the news that the vad had not restarted after the controller was exchanged.An attempt was made to switch to the previous primary controller, but this attempt was also unsuccessful.Upon reviewing the patient¿s condition and clinical signs, the patient was stable and had adequate perfusion and good blood pressure; the patient was transferred to intensive care unit (icu).Despite multiple attempts under a variety of conditions, a restart could not be achieved.The medical team was consulted several times to discuss a variety of options, such as a vad exchange or termination of vad therapy.Since the patient was stable, it was decided to preform further diagnostics and appropriate imaging to make further decisions based on this information.The vad replacement was probably out of the question by this time, in part due to the patient¿s history of previous neurologic disease.A decision was made to perform a restart attempt with the new software by updating a controller via the monitor the following day.The necessary documents such as acknowledgment form, patient consent form and a sp ecial permit were sent to the responsible physician; along with new controllers and batteries in which were transferred from another hospital.Despite several attempts, different settings on the new controller, two fully charged new batteries and ac adapter, the vad did not restart.Log files from the new controller were not taken after the restart attempts.A computerized tomography (ct) scan was performed with contrast to evaluate if there was any flow in the outflow graft (ofg) or vad and revealed no thrombus in the ofg.No statement could be made about the flow through the vad.Therapy was considered terminated, but closure of the outflow graft by occlusion or ligation was not performed.The patient was stable even after treatment requiring only optimized heart failure medication and the driveline was cut off.
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Event Description
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It was further reported that the patient was transferred from home to the hospital where the patient was placed in the intensive care unit (icu).An attempt to restart the vad with the new software was performed.It was stated there was a defect on the controller port one as a specific power source could not be identified as the cause of the issue.There was a low priority alarms in the background such as power disconnect alternating with high priority alarms such as critical battery which were self-limiting.
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Manufacturer Narrative
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A supplemental report is being submitted for additional event details.The event description, the outcome attributed to adverse event , and the annex f codes have been updated.Additional products: d4: serial #: (b)(6) h6: imf code(s): f08, f12 d4: serial#: (b)(6) h6: imf code(s): f08, f12 h6: fda device code(s): a12 d4: serial or lot#: (b)(6) h6: imf code(s): f08, f12 h6: fda device code(s): a12 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 an update to the product event summary: h6.Eval code method (fdm/annex b) for the vad.Product event summary: the ventricular assist device (vad) ((b)(6)) was not returned for evaluation.Three (3) controllers (b)(6), and four (4) batteries (b)(6) were returned for evaluation.Review of the vad's manufacturing documentation confirmed that the associated device met all requirements for release.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) and (b)(6) revealed the controllers passed visual inspection and functional testing.Failure analysis of the batteries revealed that the devices passed functional testing; the batteries were able to able to connect securely to a test controller and properly provide power.Visual inspection of the batteries revealed wear to the connector of the batteries; however, the observed damage did not affect the functionality of the devices.Failure analysis of (b)(6) revealed slightly bent pins within both power ports.Despite the bent pins, a battery was still able to connect to the controller.Additionally, visual inspection revealed contamination within both power ports of the controller.The observed contamination within the controller ports event is an additio nal finding not related to the reported event and can be attributed to the handling of the device.Functional testing of (b)(6) revealed that the controller was unable to communicate with external power sources and the display was not showing information, resulting in critical battery alarms.Additionally, the controller exhibited cyclical controller reset events.However, the controller was still able to receive power from power sources and supply power to a motor fixture.Internal inspection of the controller revealed a damaged diode on the communication line and a damaged integrated circuit which are responsible for the communication between the controller and batteries.The damaged integrated circuit is connected to the user interface controller (uic) responsible for the operations of the controller; the damaged integrated circuit prevented the controller from reading battery information and caused the controller to trigger the critical battery alarms, as well as the controller reset events observed in the controller log files.The damaged integrated circuit is also connected to the real time clock circuit and caused the date/time stamp to remain frozen.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use during the reported event.Review of the alarm log file associated with (b)(6) revealed a critical battery alarm involving (b)(6) logged with an incorrect date stamp, battery capacity, id, or cycle count, indicating that the controller was unable to properly communicate with the connected battery.Review of the alarm log file associated with (b)(6) also revealed several critical battery alarms logged with an incorrect date stamp, battery capacity, id, or cycle count, indicating that the controller was unable to recognize the connected batteries.Several vad disconnect alarms were also logged with the incorrect time/date stamp, indicating physical disconnections of the driveline from the controller, likely during a controller exchange and/or an attempt at troubleshooting.In addition, three (3) vad stopped alarms were logged with an incorrect date stamp, battery capacity, id, or cycle count, indicating that the pump failed to restart after multiple attempts.Analysis of the alarm log file did not reveal any power disconnect alarms; however, review of data log file associated with (b)(6) revealed multiple data points with a battery relative state of charge (rsoc) value of either 0% or 101% logged with incorrect date/time stamps and no serial number ids or cycle counts, indicating that the controller was unable to recognize the connected batteries.Instances with the batteries' relative state of charge (rsoc) values logged between 101-201 are indicative of communication errors.A communication error will trigger a power disconnect alarm if the other power source has an rsoc greater than 25%.Review of the event log file associated with (b)(6) revealed several controller power ups logged with an incorrect time/date stamp, likely due to troubleshooting of the controller and/or a controller exchange.Review of (b)(6) event log file also revealed multiple controller reset events with incorrect date and time stamps.Review of the controller log files associated with (b)(6) revealed a controller power up event logged on (b)(6) 2022 18:51:01, indicating that the controller was put into use following the reported controller exchange.Additionally, a subsequent vad disconnect alarms was logged at 18:51:08 indicating the controller was powered on without the driveline connected.Review of the alarm log file associated with (b)(6) revealed a vad stopped alarm logged on (b)(6) 2022 at 18:51:35, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events, additional vad stopped alarms indicating that the pump failed to restart after several attempts, and an additional vad disconnect alarm due to a physical disconnection of the driveline from the controller, likely due to troubleshooting.Review of the controller log files associated with (b)(6) revealed three (3) controller power up events logged on (b)(6) 2022 at 13:07:38, 13:15:30, and 13:22:49, due to the initial set up of the controller and that the controller was put into use.Review of the alarm log file associated with (b)(6) revealed a vad stopped alarm logged on (b)(6) 2022 at 13:28:07, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events and additional vad stopped alarms indicating that the pump failed to restart after several attempts, likely due to troubleshooting.(b)(6) was loaded with a software containing an unapproved pump start algorithm.As a result, the reported events were confirmed.Based on an investigation conducted under capa pr00384004, the root cause of observed bent socket pins within power port connectors is attributed to misalignment during connection attempts between the metal receptacles on the controller and the plastic connector plugs in the battery and/or adapter cables, which likely contributed to the reported event.The misalignment results in wear on the connector plugs that can lead to contact between the connector plug and socket pins from the controller.The socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.Based on the available information, the most likely root cause of the observed damage to the power source connectors can be attributed to wear, likely due to normal disconnection and reconnection between the power sources' output cables and metal power port connectors on the controller.Capa pr00384004 was opened to investigate bent/damaged pins with controller 2.0 and damaged cable connectors.The most likely root cause of the reported real time clock errors, critical battery alarm, inability of the controller to recognize the batteries, display error, communication errors, power disconnect alarms, and observed controller reset events can be attributed to a damaged diode and damaged integrated circuit.A possible root cause for the damaged diode and integrated circuit on the communication line can be attributed to a voltage spike on the communication pin of the connector.Capa pr00465502 was opened to investigate this issue.The most likely root cause of the observed vad disconnect alarms can be attributed to physical disconnections of the driveline from the controller during the controller exchange and troubleshooting of the vad stopped alarms.The most likely root cause of the controller power up events involving the controllers can be attributed to a controller exchange and troubleshooting of the vad stopped alarms.The most likely root cause of the reported vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.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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Manufacturer Narrative
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###a supplemental is being submitted for additional information.Product event summary: ventricular assist device (vad) (b)(6) was not returned for evaluation.Three (3) controllers ((b)(6)), and four (4) batteries ((b)(6)) were returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of (b)(6) and (b)(6) revealed the controllers passed visual inspection and functional testing.Failure analysis of the batteries revealed that the devices passed functional testing; the batteries were able to able to connect securely to a test controller and properly provide power.Visual inspection of the batteries revealed wear to the connector of the batteries; however, the observed damage did not affect the functionality of the devices.Failure analysis of (b)(6) revealed slightly bent pins within both power ports.Despite the bent pins, a battery was still able to connect to the controller.Additionally, visual inspection revealed contamination within both power ports of the controller.The observed contamination within the controller ports event is an additional finding not related to the reported event and can be attributed to the handling of the device.Functional testing of (b)(6) revealed that the controller was unable to communicate with external power sources and the display was not showing information, resulting in critical battery alarms.Additionally, the controller exhibited cyclical controller reset events.However, the controller was still able to receive power from power sources and supply power to a motor fixture.Internal inspection of the controller revealed a damaged diode on the communication line and a damaged integrated circuit which are responsible for the communication between the controller and batteries.The damaged integrated circuit is connected to the user interface controller (uic) responsible for the operations of the controller; the damaged integrated circuit prevented the controller from reading battery information and caused the controller to trigger the critical battery alarms, as well as the controller reset events observed in the controller log files.The damaged integrated circuit is also connected to the real time clock circuit and caused the date/time stamp to remain frozen.Log file analysis revealed that (b)(6) was the patient's primary controller, initially in use during the reported event.Review of the alarm log file associated with (b)(6) revealed a critical battery alarm involving (b)(6) logged with an incorrect date stamp, battery capacity, id, or cycle count, indicating that the controller was unable to properly communicate with the connected battery.Review of the alarm log file associated with (b)(6) also revealed several critical battery alarms logged with an incorrect date stamp, battery capacity, id, or cycle count, indicating that the controller was unable to recognize the connected batteries.Several vad disconnect alarms were also logged with the incorrect time/date stamp, indicating physical disconnections of the driveline from the controller, likely during a controller exchange and/or an attempt at troubleshooting.In addition, three (3) vad stopped alarms were logged with an incorrect date stamp, battery capacity, id, or cycle count, indicating that the pump failed to restart after multiple attempts.Analysis of the alarm log file did not reveal any power disconnect alarms; however, review of data log file associated with (b)(6) revealed multiple data points with a battery relative state of charge (rsoc) value of either 0% or 101% logged with incorrect date/time stamps and no serial number ids or cycle counts, indicating that the controller was unable to recognize the connected batteries.Instances with the batteries' relative state of charge (rsoc) values logged between 101-201 are indicative of communication errors.A communication error will trigger a power disconnect alarm if the other power source has an rsoc greater than 25%.Review of the event log file associated with (b)(6) revealed several controller power ups logged with an incorrect time/date stamp, likely due to troubleshooting of the controller and/or a controller exchange.Review of (b)(6) event log file also revealed multiple controller reset events with incorrect date and time stamps.Review of the controller log files associated with (b)(6) revealed a controller power up event logged on (b)(6) 2022 18:51:01, indicating that the controller was put into use following the reported controller exchange.Additionally, a subsequent vad disconnect alarms was logged at 18:51:08 indicating the controller was powered on without the driveline connected.Review of the alarm log file associated with (b)(6) revealed a vad stopped alarm logged on (b)(6) 2022 at 18:51:35, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events, additional vad stopped alarms indicating that the pump failed to restart after several attempts, and an additional vad disconnect alarm due to a physical disconnection of the driveline from the controller, likely due to troubleshooting.Review of the controller log files associated with (b)(6) revealed three (3) controller power up events logged on (b)(6) 2022 at 13:07:38, 13:15:30, and 13:22:49, due to the initial set up of the controller and that the controller was put into use.Review of the alarm log file associated with (b)(6) revealed a vad stopped alarm logged on (b)(6) 2022 at 13:28:07, indicating that the pump failed to restart after several attempts.This vad stopped alarm was followed by additional controller power up events and additional vad stopped alarms indicating that the pump failed to restart after several attempts, likely due to troubleshooting.(b)(6) was loaded with a software containing an unapproved pump start algorithm.As a result, the reported events were confirmed.Based on an investigation conducted under capa pr00384004, the root cause of observed bent socket pins within power port connectors is attributed to misalignment during connection attempts between the metal receptacles on the controller and the plastic connector plugs in the battery and/or adapter cables, which likely contributed to the reported event.The misalignment results in wear on the connector plugs that can lead to contact between the connector plug and socket pins from the controller.The socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.Based on the available information, the most likely root cause of the observed damage to the power source connectors can be attributed to wear, likely due to normal disconnection and reconnection between the power sources' output cables and metal power port connectors on the controller.Capa pr00384004 was opened to investigate bent/damaged pins with controller 2.0 and damaged cable connectors.The most likely root cause of the reported real time clock errors, critical battery alarm, inability of the controller to recognize the batteries, display error, communication errors, power disconnect alarms, and observed controller reset events can be attributed to a damaged diode and damaged integrated circuit.A possible root cause for the damaged diode and integrated circuit on the communication line can be attributed to a voltage spike on the communication pin of the connector.Capa pr00465502 was opened to investigate this issue.The most likely root cause of the observed vad disconnect alarms can be attributed to physical disconnections of the driveline from the controller during the controller exchange and troubleshooting of the vad stopped alarms.The most likely root cause of the controller power up events involving the controllers can be attributed to a controller exchange and troubleshooting of the vad stopped alarms.The most likely root cause of the reported vad stopped alarms can be attributed to failure of the pump to restart after several attempts.(b)(6) was not in scope of fca cvg-21-q3-21.Capa pr00532915 is investigating pump failures to restart outside the subpopulation of fca cvg-21-q3-21.Additional products: d1: controller d4: serial#: (b)(6) h6: fda conclusion code(s): d10, d02, d11 h6: fda method code(s): b01, b15 h6: fda results code(s): c19, c0205, c15, c02, c0706 h6: img code(s): g0201207, g0403401, g04034, g02013 d1: controller d4: serial#: (b)(6) h6: fda conclusion code(s): d10 h6: fda results code(s): c19 h6: fda method code(s): b01, b15 h6: img code(s): g04035 d1: battery d4: serial#: (b)(6) h6: fda conclusion code(s): d01 h6: fda results code(s): c07 h6: img code(s): g04034 h6: fda method code(s):b01, b15 d1: heartware ventricular assist system ¿ controller 2.0 serial#: (b)(6) h3: yes h6: img code(s): g04034 b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 d1: heartware ventricular assist system ¿ battery serial#: (b)(6) h3: yes h6: img code(s): g04034 h6: fda method code(s): b01, b15 h6: fda results code(s): c07 h6: fda conclusion code(s): d01 d1: heartware ventricular assist system ¿ battery serial#: (b)(6) h3: yes h6: img code(s): g04034 h6: fda method code(s): b01, b15 h6: fda results code(s): c07 h6: fda conclusion code(s): d01 d1: heartware ventricular assist system ¿ battery serial#: (b)(6) h3: yes h6: img code(s): g04034 h6: fda method code(s): b01, b15 h6: fda results code(s): c07 h6: fda conclusion code(s): d01 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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Manufacturer Narrative
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This report is being submitted as part of a retrospective review and remediation for capa (b)(4) per (b)(4).A correction is being submitted for an update to h1.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 a correction to h1.This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).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.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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Search Alerts/Recalls
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