|
HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
|
Back to Search Results |
|
| Model Number 1104 |
| Device Problems
Pumping Stopped (1503); Date/Time-Related Software Problem (2582); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010)
|
| Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
|
Event Type
Death
|
|
Manufacturer Narrative
|
|
Additional information has been requested regarding the log files for this event, but it was not available at the time of this report.If log files investigation is performed, the event will be updated and a supplemental report will be sent.Additional products: heartware ventricular assist system controller 2.0, model #: 1420-controller / catalog #: 1420-controller / expiration date: 31-jan-2021, lot#: (b)(4), udi #: (b)(4).Mfg date: 09-jan-2020.Labeled for single use: no.(b)(4).Heartware ventricular assist system-battery, model #: unk/ catalog #: unk/ expiration date: unk / serial or lot#: unk.Udi #: (b)(4).Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
It was reported that the patient was found deceased with one battery connected to the controller and a second battery laying in front of the patient.It was stated that the controller didn't recognize the connected battery, or the battery was not properly connected to the controller.The event was associated with losses of power to the controller and the ventricular assist device (vad) stopped.It was also noted that the controller exhibited a corrupt date entry of 2099 in the log files.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for additional patient demographic information, date of their death and device implant date.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.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for additional information, d9, h3, h10.Additional products: d1: heartware ventricular assist system-battery d4: model #: 1650de / catalog #: 1650de/ expiration date: 31-mar-2021/ serial#: (b)(6) udi #: (b)(4) h4: mfg date: 30-mar-2020 d1: heartware ventricular assist system-battery d4: model #: 1650de / catalog #: 1650de / expiration date:31-aug-2021 / serial #: (b)(6) udi #:(b)(6) d9: no h4: mfg date: 18-aug-2020 h5: no h6: patient ime code(s): e2402 h6: imf code(s): f02 h6:img code (s):g02002 h6: fda device code(s): a0705 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.
|
| |
|
Event Description
|
|
It was further reported that a shoulder pack was returned to the manufacturer and subsequently tested out-of-specification during ma nufacturer's analysis.
|
| |
|
Manufacturer Narrative
|
|
A supplemental report is being submitted for device evaluation.Product event summary: the pump, one (1) controller, two (2) batteries, and one (1) shoulder pack were returned for evaluation.No performance allegations were made against the shoulder pack.A review of the pump'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 devices in relation to the reported event.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front preload measurement, rear housing disc curvature, and front housing disc curvature were found to be deviating from specifications.Internal pathological report revealed no evidence of thrombus within the device.Failure analysis of the returned shoulder pack revealed a damaged viewing window.This is an additional finding not related to the reported event.The most likely root cause of the observed damaged viewing window event can be attributed, but not limited to wear and/or due to the handling of the pack.Capa pr00519581 was created to investigate damaged packs.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection revealed contamination within both power ports.This is an additional finding not related to the reported event and can be attributed to handling of the device.Failure analysis of (b)(6) revealed that the battery passed visual inspection and functional testing.Failure analysis of the returned (b)(6) revealed that the battery passed visual inspection.Functional testing revealed that the battery was unable to charge or provide power due to an enabled safety flag.This safety flag indicates that there was a communication error between the main integrated circuit (ic) that monitors the battery and reports information to the controller and the ic that measures cell pair voltages and provides safety protection when certain conditions are met.This communication error caused the battery to trigger a safety flag and become inoperable.A reset of both integrated circuits was able to remove the flag and resulted in the battery regaining functionality.Review of the controller log files revealed fifty-five (55) controller power up event with associated pump start events were logged between (b)(6) 2021 at 00:52:17 and (b)(6) 2021 16:08:28.No anomalies were observed leading up to the losses of power.The controller was without power for an average of 20 seconds per loss of power.Log file analysis revealed a controller power up event recorded on (b)(6) 2021 at 08:07:52.Review of the event log file revealed that the controller last had power on (b)(6) 2021 at 20:35:58.The data point prior to the controller power up event, recorded on the controller's internal log, was logged on (b)(6) 2021 at 20:33:38, which revealed that (b)(6) was connected to power port one (1) with 73% relative state of charge (rsoc) and (b)(6) was connected to power port two (2) with 74% rsoc.No anomalies were recorded leading up to the loss of power.Review of the data log file also revealed one data point recorded on (b)(6) 2021 after 17:59:39 with the date/time stamp of 31-feb-99 at 00:00:00.Additionally , multiple low flow alarms were logged since (b)(6) 2021.As a result, the reported battery not recognized by the controller, controller losses of power, and "corrupt date entry of 2099" events were confirmed.Further investigation using a representative sample revealed that the reported event can be replicated when the controller is exposed to voltage spikes or noise caused when connecting a battery to the controller, resulting in a temporary loss of communication between the real time clock circuit and the user interface circuit (uic).The uic is responsible for operation of the controller, including recording data in the controller log files.Therefore, the loss of communication caused the controller to record an invalid date and/or time in the data log file.Based on the available information, the most likely root cause of the reported event can be attributed to a voltage spike or noise caused when connecting a battery to the controller.Based on the risk documentation, possible causes of the observed 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, poo r vad filling, inappropriate pump rotational speed.A possible root cause of the losses of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa r00551638 is investigating controller losses of power.Based on an investigation conducted under capa pr00519785, the most likely root cause of the reported battery not recognized by the controller event has been attributed to the battery connector interface design which does not guarantee the desired connection angle in some use conditions.Additional products: d4: serial or lot#: (b)(6) d9: yes, return date: 30-sep-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): c02, c15 h6: fda conclusion code(s): d15, d02, d11 d4: serial or lot#: (b)(6) d9: yes, return date: 30-sep-2021 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 d4: serial or lot#: (b)(6) d9: yes, return date: 30-sep-2021 h3: yes dev rtn to mfr? yes h6: img code(s): g02013 h6: fda method code(s): b01, b15 h6: fda results code(s): c02 h6: fda conclusion code(s): d01 d1: heartware ventricular assist system ¿ shoulder pack d4: model #: unk / catalog #: unk / expiration date: unk / serial or lot#: unk udi #: asku d9: yes, return date: 30-sep-2021 h3: yes dev rtn to mfr? yes h4: mfg date: unk h5: no h6: patient ime code(s): e2402 h6: imf code(s): f02 h6: img code(s): g04141 h6: fda device code(s): a04 h6: fda method code(s): b01 h6: fda results code(s): c0601 h6: fda conclusion code(s): d11 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.
|
| |
|
Search Alerts/Recalls
|
|
|
