Manufacturer¿s investigation conclusion a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) and the reported events could not be conclusively established through this evaluation.Additionally, a review of the submitted log files confirmed a pump stop that appeared consistent with an electrostatic discharge (esd) event; however, a specific cause could not conclusively be determined through this evaluation.The system controller log file captured a pump stop event on (b)(6)2020 at 10:08:11 lasting approximately 3 seconds.The pump stoppage appeared consistent with an esd event causing the left ventricular assist device (lvad) software to reset, which is in accordance with the intended design.Additionally, transient pi events were also observed, resulting in momentary decreases in speed per design.The pump appeared to function as intended.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).Multiple attempts for additional information were made and no further detail was provided.The heartmate 3 lvas instructions for use (ifu) is currently available.Device thrombus and peripheral thromboembolic events as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document lists thromboembolism as a potential late postimplant complication and provides information regarding anticoagulation, including the recommended inr values.The patient care and management section warns about static electricity and explains how it should be avoided.The static electric discharge section explains that strong static discharges should be avoided.The alarms and troubleshooting section provides information regarding system alarms and steps to resolve them.Additionally, the safety testing and classification tables in section b of this ifu include electrostatic discharge information.The heartmate 3 lvas patient handbook is also available.Section 1 warns not to touch the television or computer screen, and not to vacuum or engage in activities that create static electricity.This section also explains that a strong electric shock can damage electrical parts of the system and cause the pump to stop.Additionally, the safety testing and classification tables in section 9 include electrostatic discharge.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 09may2016.No further information was provided.The manufacturer is closing the file on this event.
|