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It was reported that the patient was admitted (b)(6) 2020 for acute decompensated heart failure (adhf).Patient has been in the intensive care unit (icu) since (b)(6) 2020 now requiring continuous renal replacement therapy (crrt), inhaled nitric oxide therapy (ino) and pressor support.Patient¿s speed increased from 6000 to 6800 on (b)(6) 2020.Per interrogation, flows started to drop around (b)(6) 2020, less than 3.0 lpm.Pi was staying low 2s.Cvp (central venous pressure) was 6 mmhg.The vad team was concerned as to why flows and pi were staying low in this setting.The left ventricle did not seem to be unloading.Echo results from (b)(6) 2020 stated that the left ventricle was severely enlarged with severely decreased systolic function.The estimated ejection fraction was 10%.There was left ventricular eccentric hypertrophy and diastolic dysfunction.Septal wall had abnormal motion consistent with left bundle branch block.Lvad present with base speed at 6000 rpms.The interventricular septum appeared to bow into the right ventricle.The aortic valve opened normally.Left ventricular internal diameter end diastole (lvidd) was 7.70 cm.Mild right ventricular enlargement.Mildly reduced right ventricular systolic function.Mild-to-moderate mitral regurgitation.The aortic valve opened with each cardiac cycle.The ventricular septum bows right.Echo results from (b)(6) 2020 stated that the base speed was 6800 rpms.The interventricular septum appeared to bow into the right ventricle.The aortic valve opened normally.The left ventricle was severely enlarged with severely decreased systolic function.The estimated ejection fraction was less than 10%.Left ventricular volume was not significantly changed from the prior study.Moderate right ventricular enlargement.Mildly to moderately reduced right ventricular systolic function.Grade ii diastolic dysfunction.Severe left atrial enlargement.Moderate mitral regurgitation.Mild tricuspid regurgitation.The estimated pulmonary artery pressure (pa) systolic pressure was 44 mmhg.Intermediate central venous pressure was 8 mmhg.The aortic valve opened with each cardiac cycle.The ventricular septum bowed right.Echo results from (b)(6) 2020 stated that the base speed was 6800 rpms.The left ventricle was still severely enlarged with severely decreased systolic function.The estimated ejection fraction was 13%.The interventricular septum appeared to bow into the right ventricle.The aortic valve opened normally.There were segmental left ventricular wall motion abnormalities.There was severe left ventricular eccentric hypertrophy.Septal wall had abnormal motion.Diastolic dysfunction.Mild left atrial enlargement.Moderate right ventricular enlargement.Low normal right ventricular systolic function.Moderate right atrial enlargement.Moderate-to-severe mitral regurgitation.Mild tricuspid regurgitation.Normal central venous pressure was 3 mmhg.The estimated pa systolic pressure was 34 mmhg.The aortic valve opened with each cardiac cycle.The ventricular septum bowed right.The event log file noted the fixed speed change on (b)(6) 2020 from 6000 rpm to 6800 rpm and calculated flow did change and drop from mid 3¿s to under 3 lpm around (b)(6) 2020 with the pi remaining fairly stable in the 2¿s since 09oct2020 when the speed was increased.It was reported that the clinic sent in more log files for analysis.The patient started having low flow alarms (lfa), dropping to 2.4 lpm and 2.3 lpm, and the patient was not responding too much and was taken to ct scan.Patient woke up more and started responding more.First set of waveforms are from when lfa started.Second set of waveforms are after all events, lfa was still alarming currently, speed increased to 7100 rpm.Pump sounded like it was lagging.The event log contained numerous low flow estimates as well as sustained low flow hazard alarms throughout the log file.The calculated flow appears to be fluctuating near the alarm threshold of 2.5lpm.These flow readings did not appear to be the result of any pump malfunction.An obstruction was suspected.It was reported that the patient's sepsis may have contributed to this event.The patient's speed increased, lfa persistent since (b)(6) 2020 as low as 1.7 lpm.Ct scan showed that although 100 ml of omnipaque 350 were implied for contrast enhancement, enhancement of vascular structures was limited including the outflow cannula of the lvad.In order to improve assessment of vascular structures, images were reviewed with conventional window and level settings as well as on narrow windows between 250 and 350 hounsfield units with level between 45 and 60 hounsfield units.In particular, internal detail of the outflow cannula was limited just distal to the metal reinforcing structure along the proximal outflow cannula at the level of the most inferior sternal wire.Given that the patient was maintained on hemodialysis re-evaluation was considered with a larger dose of contrast medium for better enhancement of vascular structures and outflow cannula if patient was able to tolerate that larger dose.The patient was do not resuscitate (dnr).The patient is treated with persistent lfa.Patient was also on levophed and inotropes.No equipment was exchanged.Obstruction had not been officially diagnosed as the ct images were of very poor quality.It was later reported that the patient passed away on (b)(6) 2020 due to multi-system organ failure.
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Manufacturer's investigation conclusion: a specific cause for the reported events and a direct correlation to heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively determined through this evaluation.Although obstruction was suspected, the type of obstruction was not reported by the account and could not be confirmed through this evaluation as no images were provided for review and the device was not returned.Additionally, review of the submitted log files confirmed low flow alarms; however, a specific cause for these events could not be conclusively determined.The account reported that the patient was admitted on (b)(6) 2020 for acute decompensating heart failure (adhf).The patient was kept in the intensive care unit (icu) since (b)(6) 2020 and required continuous renal replacement therapy (crrt), inhaled nitric oxide (ino) and pressor support.Despite increasing the pump¿s speed, flow began to drop to less than 3.0 liters per minute (lpm) and pulsatility index (pi) remained in the low 2s.The patient¿s central venous pressure (cvp) was 6 on (b)(6) 2020.Multiple echocardiograms (echos) were performed which revealed right ventricular dysfunction and mitral and tricuspid valve regurgitation.The patient¿s left ventricle (lv) also did not appear to be unloading.By (b)(6) 2020, the patient¿s flows had reportedly dropped to 2.3-2.4 lpm.The patient was not responding too much and was taken for a computed tomography (ct) scan, following which, the patient woke up and started responding more.Low flow alarms were observed despite increasing the pump¿s speed to 7100 rpm.The account also reported that the pump sounded like it was lagging.The controller event log files collectively contained data from 20:32:41 on (b)(6) 2020 through 15:28:55 on (b)(6) 2020 and from 10:27:36 through 15:27:27 on (b)(6) 2020, per the timestamps.An overall decrease in estimated flow was observed, with values dropping below 3.0 lpm beginning on (b)(6) 2020.Transient low flow fault flags were captured on (b)(6) 2020 due to the estimated flow frequently dropping below the low flow threshold of 2.5 lpm, to 2.4 lpm.These faults resulted in a total of 15 low flow hazard alarms, with some lasting longer than 14 minutes in duration.The remaining faults did not last long enough to trigger low flow hazard alarms.Despite the observed events, the pump appeared to function as intended at the set speed.Additional information stated that the patient¿s right ventricular (rv) failure was complicated by sepsis and multiorgan failure.The patient¿s ct images were of very poor quality; therefore, an obstruction was never officially diagnosed.The patient continued to have persistent low flow alarms and was placed on levo and inhaled nitric oxide (ino).No equipment was exchanged as the patient was classified as do not resuscitate (dnr).It was later reported that the patient expired due to multi-system organ failure on (b)(6) 2020.The death was not considered to be device related.It was also communicated that heartmate 3 lvas, serial number (b)(6), would not be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2019.The hm 3 lvas instructions for use (ifu) lists sepsis, multiple types of organ failure and dysfunction (including right heart failure, respiratory failure, renal dysfunction, and hepatic dysfunction) as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Although only sepsis was reported by the account, several sections of the hm3 lvas ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.This document states that patients may develop right ventricular failure during or shortly after implant and outlines the associated treatment options.The ifu further explains that right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.The ifu instructs the user to inspect the ventricle and remove any previously formed clots that may cause embolism or any trabeculae that may impede flow, and to address both as needed.This document outlines considerations for pump placement and orientation, and provides instructions regarding the preparation, installation, and orientation of the sealed inflow conduit.The ifu also outlines preparing and installing the sealed outflow graft and instructs to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.In reference to pump flow, the ifu states that per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.The ifu also explains that changes in patient conditions can result in low flow.Furthermore, the hm3 ifu and patient handbook describe all advisory and hazard alarm conditions as well as the appropriate actions associated with them.No further information was provided.The manufacturer is closing the file on this event.
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