Manufacturer's investigation conclusion: a direct cause for the patient¿s sepsis could not be conclusively determined through this evaluation.Additionally, a direct relationship between the device and the reported subarachnoid hemorrhage and patient outcome could not be conclusively determined through this evaluation.Multiple requests for additional information were issued to the customer; however, no further information was provided.The pump was not returned for evaluation.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 lvas ifu is currently available.The heartmate 3 lvas ifu lists sepsis, stroke, death as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.This document provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.Care instructions in regard to preventing infection are included in several sections of the ifu, including in section 6 "patient care and management" (under "caution!", "caring for the driveline exit site", and "controlling infection").Section 6 also provides suggested responses in the event of infection.The heartmate 3 lvas patient handbook provides care instructions in regard to preventing infection in several sections, including section 4 ¿living with the heartmate 3¿ (under ¿caring for the driveline exit site¿).The patient handbook instructs the patient to call their hospital contact immediately if any signs of infection are noticed no further information was provided.The manufacturer is closing the file on this event.
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