Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the report of right heart failure, respiratory failure, and bleeding could not be conclusively established through this evaluation.Additionally, the reported low flows could not be confirmed through this investigation, and a specific cause for the low flows could not be determined.Per the ventricular assist device (vad) coordinator, the device will not be returned for evaluation.The heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu) lists bleeding, respiratory failure, right heart failure, and death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document also provides information regarding anticoagulation, including recommended inr values, and the suggested anticoagulation modifications in the event that there is a risk of bleeding.The ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and notes that changes in patient conditions can result in low flow.This ifu also describes all system alarms and the recommended actions associated with them.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 13aug2020.No further information was provided.The manufacturer is closing the file on this event.
|