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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1103 |
| Device Problems
Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)
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| Patient Problem
Low Cardiac Output (2501)
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| Event Date 07/13/2022 |
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Event Type
Death
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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: heartware ventricular assist system ¿controller 2.0 model #: 1420 / catalog #: 1420 / expiration date: 31-mar-2021 / serial #: (b)(4) udi #: (b)(4) , device evaluation anticipated, but not yet begun.Mfg date: 10-mar-2020 no h6: patient ime code(s): (b)(6) h6: imf code(s): f02, f08, f2303 h6: img code(s): g04035 h6: fda device code(s): a1203, a0708, a1108 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-apr-2022 / serial #: (b)(4) udi #: (b)(4) d9: device evaluation anticipated, but not yet begun h4: mfg date: 26-apr-2021 h5: no h6: patient ime code(s): (b)(4) h6: imf code(s): (b)(4) h6: img code(s): (b)(4) h6: fda device code(s): (b)(4) h6: additional products: heartware ventricular assist system ¿cac adapter d4: model #: unk / catalog #: unk / expiration date: unk / serial #: unk udi #: unk d9: device evaluation anticipated, but not yet begun h4: mfg date: unk h5: no h6: patient ime code(s): (b)(4) h6: imf code(s): (b)(4) h6: img code(s): (b)(4) h6: d1: heartware ventricular assist system ¿ controller 2.0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2023 / serial #: (b)(4) udi #: (b)(4) d9: device evaluation anticipated, but not yet begun h4: mfg date: 24-jan-2022 h5: no h6: patient ime code(s): (b)(4) h6: imf code(s): (b)(4) h6: img code(s): (b)(4) additional information has been requested regarding event details, 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 the patient was at a rehabilitation center and the staff heard an alarm from the ventricular assist device (vad).The staff entered and saw ¿vad stop change controller,¿ but could not find the patient¿s backup controller.The patient was transported to the hospital where a controller exchange was attempted without success.It was noted that the patient had a double power disconnect and the vad failed to restart despite several attempts.Log file review noted low flow alarms and unexpected power loss on the controller.It was noted that a battery and controller ac adapter were connected to the controller prior to the controller power up.It was also noted that the controller time was off by one hour, where the controller read 10:05 but real time was 11:05.The patient was placed on inotropes.As the patient was do-not-resuscitate (dnr)/do-not-intubate (dni), it was decided to not attempt any further controller exchanges to avoid a possible stroke.The patient remained on inotropes and care was withdrawn.It was noted that the vad was off, so the patient had low cardiac output.The patient subsequently died.
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Manufacturer Narrative
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A supplemental report is being submitted as additional information has being received for this event.Updated section: b9 device available for evaluation and return date h3 device returned to mfr additional products: d1: heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-apr-2022 / serial #: (b)(6), udi #: (b)(4), d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 21-apr-2021 h5: no h6: patient ime code(s): e0613 h6: imf code(s): f02, f08, f2303 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-apr-2022 / serial #: (b)(6), udi #: (b)(4), d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 26-apr-2021 h5: no h6: patient ime code(s): e0613 h6: imf code(s): f02, f08, f2303 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 31-aug-2022 / serial #: (b)(6), udi #: (b)(4), d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 24-aug-2021 h5: no h6: patient ime code(s): e0613 h6: imf code(s): f02, f08, f2303 h6: img code(s): g02002 h6: fda device code(s): a0705 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿cac adapter d4: model #:1425 / catalog #:1425 / expiration date: / serial #: (b)(6), 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 additional information.Additional information was received in a4 and b7.This supplemental is based solely on the receipt of a 3500a report.Section f has been updated to reflect that report.F1 user facility f2 uf/importer report number: (b)(4).F3 user facility name/address: (b)(6) hospital center (b)(6).F4 contact person: (b)(6).F6 date user facility became aware of the event: unknown f7 type of report: initial.F8 date of this report: jul-2022.F9 approximate age of device: 4 years.F10 event problem codes: n/a.F11 report sent to fda: unknown f12 location where event occurred: unknown f13 report sent to manufacturer: yes, aug-2022 f14 manufacturer name and address: mfr.Name: medtronic address: 8200 coral sea street ne city: mounds view state: mn zip: 55112.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 is being submitted for additional information.Product event summary: ventricular assist device (b)(6), two (2) controllers (b)(6), four (4) batteries (b)(6), and one (1) controller ac adapter (cac106901) were returned for evaluation.A review of the pump¿s manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned controller and batteries revealed that the devices passed visual examination and functional testing.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Internal pathological report revealed no evidence of thrombus within the device.Dimensional verification revealed that the rear housing disc curvature and front housing disc curvature were found to be deviating from specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Further analysis revealed outer shroud contact that created more friction at the housing to impeller interface, this increase in friction is being investigated under the capa pr00532915 investigation.Log file analysis revealed that (b)(6) was the primary controller, initially in use during the reported event date.Review of the controller log files associated with (b)(6) revealed two (2) controller power up events logged on 15-jul-2022 at 10:04:13 and 10 :04:44.The data point prior to the losses of power revealed that no power source was connected to power port one (1) and (b)(6) was connected to power port two (2) with 73% relative state of charge (rsoc).The data point recorded after the losses of power revealed that no power source was connected to power port (1) and (b)(6) was connected to power port two (2).No anomalies were observed leading up to the losses of power.The controller was without power for a total of 1 minute and 48 seconds.After the controller power up event at 10:04:13, analysis of the data log file pertaining to (b)(6) revealed safety alert word (saw) values were recorded on the only connected power source, (b)(6), indicating an overcurrent alert.During the attempted pump start events, the data log file recorded high power consumption, which required more current from the battery.It is likely that the overcurrent condition prevented the battery from providing power, resulting in a loss of power to the controller.Review of the alarm log file associated with (b)(6) revealed a vad stopped alarm was then logged at 10:05:03, 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 during troubleshooting and/or the reported controller exchange.Additionally, log files associated with (b)(6) revealed one (1) low flow alarm was logged at 13-jul-2022.Analysis of the event log file revealed that the site manually set the date to 06:33:16 on 04-dec-2020, during the initial controller set up; no anomalies related to the real time clock were observed.Log file analysis associated with (b)(6) revealed three (3) controller power up events logged on 15-jul-2022 at 11:32:40, 12:06:22, and 12:06:34.Review of the data log file associated with (b)(6) revealed that the controller was not in use prior to the controller power up events; the first data point was logged at 12:07:10, indicating that the power up events occurred during a controller exchange.After the controller power up event at 12:06:22, analysis of the data log file pertaining to (b)(6) revealed saw values were recorded on the only connected power source, (b)(6), indicating an overcurrent alert.During the attempted pump start events, the data log file recorded high power consumption, which required more current from the battery.It is likely that the overcurrent condition prevented the battery from providing power, resulting in a loss of power to the controller.Review of the alarm log file associated with (b)(6) then revealed a vad stopped alarm was logged at 12:06:52, 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.As a result, the reported low flow, loss of power, and vad stop events were confirmed.The reported real clock time error event was not confirmed.The most likely root cause of the reported "clock time was off" event can be attributed to the initial programming of the date/time during the initial set up of the controller.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.A possible root cause of the losses of power can be attributed to a disconnection of both power sources, to an intermittent disconnection on one or both power sources and/or troubleshooting of the vad stopped alarms.Capa pr00551638 is investigating controller losses of power.Capa pr00544941 is investigating controller losses of power during pump start due to battery discharge overcurrent condition.The most likely root cause of the vad stopped alarms can be attributed to failures 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: (b)(6)¿controller 2.0 d9: yes, return date: 08-feb-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d10, d15 (b)(6)¿battery d9: yes, return date: 08-feb-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 additional products: cac106901¿cac adapter d9: yes, return date: 08-feb-2023 h3: yes dev rtn to mfr? yes h4: mfg date: 21-apr-2017 h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6) ¿ controller 2.0 d9: yes, return date: 08-feb-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d10 (b)(6)¿battery d9: yes, return date: 08-feb-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6)¿battery d9: yes, return date: 08-feb-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 (b)(6)¿battery d9: yes, return date: 08-feb-2023 h3: yes dev rtn to mfr? yes h6: fda method code(s): b15, b01 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 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.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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