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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 1.0; VENTRICULAR (ASSIST) BYPASS
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| Model Number 1407GB |
| Device Problems
Loose or Intermittent Connection (1371); Device Inoperable (1663); Date/Time-Related Software Problem (2582); Device Displays Incorrect Message (2591); Power Problem (3010)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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| Event Date 05/05/2018 |
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Event Type
malfunction
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Manufacturer Narrative
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This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Other devices involved in this event: heartware ventricular assist system ¿battery / (b)(4)/ model #: 1650de / expiration date: 2017-01-31, device evaluation anticipated, but not yet begun mfg date: 2016-01-31 (b)(4).Heartware ventricular assist system ¿battery / (b)(4)/ model #: 1650de / expiration date: 2017-01-31, device evaluation anticipated, but not yet begun mfg date: 2016-01-31 (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 controller had a loose connector on one of the ports.There were critical battery alarms and no power alarms, and power switching occurred.The pump stopped for approximately ten minutes.It was noted that there were erroneous timestamps on the log file due to an internal controller issue.One battery had a damaged cable with exposed wires.That battery and another battery did not provide power.The controller and batteries were exchanged.The patient experienced no symptoms related to the pump stop.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: two controllers were returned for evaluation.Two batteries were not returned for evaluation.A review of the manufacturing documentation confirmed that both controllers met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the returned controllers in relation to the reported event.Failure analysis of the returned con191672 revealed that the power port 1 connector, as well as its nut and washer were loose.An internal inspection did not reveal evidence of fluid ingress.Functional testing of the returned controller revealed that it could not establish stable communication with its power sources.Internal inspection of the controller revealed a damaged transient voltage suppressor (tvs) diode on the communication line pertaining to power port 1.A tvs diode is designed to protect sensitive components from sudden voltage spikes.Electrical evaluation of the controller panel and power board revealed that the integrated circuit (ic) responsible for the communication between the controller and batteries was damaged.This damaged integrated circuit is also connected to the real time clock circuit and may have caused the date and time stamp to remain frozen.Further analysis revealed that the power port nut came in contact with the printed circuit board (pcb), causing the damage to tvs diode and integrated circuits.Failure analysis of the returned con187659 revealed a loose power port 1 connector and the o-ring gasket displaced.An internal inspection did not reveal evidence of fluid ingress.Functional testing of con187659 revealed that the real-time clock (rtc) was reset to zero.Analysis of log files associated with con191672 revealed that the controller contained a feature that records whether a power source experienced a communication error or disconnection within each 15-minute interval.Analysis of data log files revealed several power switching events that were due to momentary disconnections involving batteries bat213377 and bat213383.Analysis of the alarm and event files revealed multiple critical battery alarms logged with an incorrect date stamp and no battery capacity or serial id, as well as multiple controller power-up events.Analysis of log files associated with con187659 revealed that the real time clock was reset to zero (year 2000); however, the logs available do not cover the event date.As a result, the reported loose connector, critical battery alarm, loss of power, power switching, and erroneous time stamp events were confirmed.The most likely root cause of the reported loose connector event can be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.The most likely root cause of the power switching events can be attributed to momentary disconnections between the controller and batteries.The most likely root cause of the reported critical battery alarm, no power, erroneous time stamp event on con191672 can be attributed to a damaged integrated circuit responsible for communicating to external batteries.The damaged integrated circuit prevented the controller from reading battery information and caused the controller to trigger critical battery alarms, as well as causing loss of power to the controller when powered by two batteries.The most likely root cause of real time clock was reset to zero (year 2000) on con187659 can be attributed to an extended period of time where the controller was not connected to an external power source, causing the real time clock to deplete.The reported "damaged cable/exposed wires and batteries did not provide power" events could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; events involving a battery not providing power can be attributed, but not limited, to an internal battery communication error, a faulty integrated circuit, improper weld and/or due to a soldering defect.Events involving batteries with damaged cables/exposed wires can be attributed, but not limited to wear and/or handling of the device.Other devices involved in this event: d1: heartware ventricular assist system - controller 1.0 d4: controller / con187659 / model #: 1407gb / expiration date: 31-oct-2015 udi #: asku d10: yes, return date: 18-jun-2019 h3: yes dev rtn to mfr? yes h4: mfg date: 31-oct-2014 h5: no h6: patient code(s): c76143 h6: device code(s): c63055, c67508 h6: fda method code(s): 10, 3331 h6: fda results code(s): 180, 213 h6: fda conclusion code(s): 12, 19 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: one controller was returned for evaluation.Two batteries were not returned for evaluation.A review of the manufacturing documentation confirmed that controller met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the returned controller in relation to the reported event.Failure analysis of the returned controller revealed the power port 1 connector, as well as its nut and washer were loose.Functional testing of the returned controller revealed that it could not establish stable communication with its power sources.Internal inspection of the controller revealed a damaged transient voltage suppressor (tvs) diode on the communication line pertaining to power port 1.A tvs diode is designed to protect sensitive components from sudden voltage spikes.Electrical evaluation of the controller panel and power board revealed that the integrated circuit (ic) responsible for the communication between the controller and batteries was damaged.This damaged integrated circuit is also connected to the real time clock circuit and may have caused the date and time stamp to remain frozen.Further analysis revealed that the power port nut came in contact with the printed circuit board (pcb), causing the damage to tvs diode and integrated circuits.Analysis of log files associated revealed that the controller contained a feature that records whether a power source experienced a communication error or disconnection within each 15 minute interval.Analysis of data log files revealed several power switching events that were due to momentary disconnections involving batteries bat213377 and bat213383.Analysis of the alarm and event files revealed multiple critical battery alarms logged with an incorrect date stamp and no battery capacity or serial id, as well as multiple controller power-up events.As a result, the reported loose connector, critical battery alarm, no power, power switching and erroneous time stamp events were confirmed.The reported "damaged cable/exposed wires and batteries did not provide power" events could not be confirmed due to insufficient evidence.Applicable risk documentation and experience with events of similar circumstances were considered; events involving a battery not providing power can be attributed, but not limited, to an internal battery communication error, a faulty integrated circuit, improper weld and/or due to a soldering defect.Events involving batteries with damaged cables/exposed wires can be attributed, but not limited to wear and/or handling of the device.The most likely root cause of the loose components can be attributed to inadequate thread lock, an inconsistent thread lock cure time and inadequate torque application during the assembly process.An internal investigation has been opened to evaluate the loose components and implement corrective actions as required.The most likely root cause of the reported critical battery alarm, no power, erroneous time stamp event can be attributed to a damaged integrated circuit responsible for communicating to external batteries.The damaged integrated circuit prevented the controller from reading battery information and caused the controller to trigger critical battery alarms, as well as causing loss of power to the controller when powered by two batteries.The most likely root cause of the power switching events can be attributed to momentary disconnections between the controller and batteries.An internal investigation has been opened to evaluate the momentary disconnections and the controller losing power and implement corrective actions as required.Additional products: battery, bat213377; concomitant medical products: no.Device evaluated by mfr: yes.Battery, bat213383; concomitant medical products: no.Device evaluated by mfr: yes.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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