Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system, serial number (b)(4), and the reported events (septic shock, patient condition, and patient expiration) could not be conclusively determined through this investigation.(b)(4) will not be returned for evaluation.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) lists death and sepsis as adverse events that may be associated with the use of heartmate 3 lvas.Care instructions in regard to preventing infection are provided in various sections of the instructions for use.No further information was provided.The manufacturer is closing the file on this event.
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