Manufacturer's investigation conclusion: the reported inflow malposition could not be confirmed through this evaluation.It was reported that inflow malposition was causing low flows.The report of low flow alarms could not be confirmed via evaluation of the extracted log files.Additionally, a direct cause of the reported driveline infection could not be determined.The evaluation of heartmate 3 lvas, serial number (b)(6), did not reveal any device-related issues.(b)(6) was returned assembled with the pump cable severed approximately 9¿ from the pump housing and the distal portion was not returned.The modular cable was not returned with the device.The sealed outflow graft and bend relief were not returned with the device.The outflow graft clip was returned separate of the device.Upon disassembly of the returned pump, examination of the blood-contacting surfaces did not reveal any developed depositions or thrombus formations that would have contributed to a flow or functional issue.Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects.(b)(6) was cleaned, rebuilt, and functionally tested on a mock circulatory loop.The device operated as intended and in accordance with manufacturing specifications.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation found no deviations from manufacturing specifications.The implant kit shipped on (b)(6) 2019.The most recent revision of the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is rev.C.This document lists infection as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.Care instructions in reference to preventing infection are provided throughout this ifu, including sections titled "caring for the driveline exit site" and "controlling infection." section 5 entitled ¿surgical procedures¿ explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This section also outlines the steps to reorient the pump.Section 4 entitled ¿system monitor¿ explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 lpm, the pump has stopped, the pump is not operating properly, or the driveline is disconnected from the system controller.Changes in patient conditions can result in low flow, such as hypertension.Section 7 entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.Heartmate 3 lvas patient handbook section 5 entitled "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document states that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.This handbook also contains information about preventing infection.No further information was provided.The manufacturer is closing the file on this event.
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