Section h6: health effect - clinical code: 3261 - multiple organ dysfunction syndrome.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events (cardiac arrhythmia, respiratory failure, and multisystem organ failure) cannot be conclusively determined through this evaluation.The patient remained ongoing on heartmate 3 lvas, serial number (b)(6), until they expired on (b)(6) 2021 (refer to manufacturer report number 2916596-2021-02839).Additional information regarding the event was requested from the account; however, no further information will be provided at this time.The relevant sections of the device history records were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu), rev.A,, contains the following information: section 1 lists cardiac arrhythmia, respiratory failure, and multiple types of organ failure as adverse events that may be associated with the use of heartmate 3 left ventricular assist system.Section 6 lists cardiac arrhythmia as a potential late post-implant complication that may be associated with the use of heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.
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