Description of Event or Problem · 0
(B)(4). MILLYARD ADVANCED MEDICAL PRODUCTS LLC RECEIVED NOTIFICATION ON 31-DEC-2021 THAT A PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM ON (B)(6) 2021. THE PATIENT NOTED A NUMBER OF SYMPTOMS INCLUDING MUSCLE CRAMPS, LIGHTHEADEDNESS, AND IT WAS DETERMINED THAT HE HAD REDUCED KIDNEY FUNCTIONALITY. THE PATIENT NOTED "CASSETTES FROM (B)(6) 2021 SHIPMENT WERE LEAKING AND DEPLETED EARLY" AND THAT "HE MIXED FROM HIS BACKUP". THE DEVICE ASSOCIATED WITH THE EVENT HAS NOT YET BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION DESPITE MULTIPLE REQUESTS. A REVIEW OF RECENT COMPLAINTS FROM THIS PATIENT WAS PERFORMED; THERE WERE (4) PRIOR REPORTS OF POTENTIAL DEVICE ISSUES FROM THIS PATIENT WITHIN THE MONTH OF (B)(6). THE REPORTS SHOW A 50% REMODULIN DOSE INCREASE OVER THE PREVIOUS 16 DAYS LEADING UP TO THE REPORTED ISSUE, WHICH CAN RESULT IN THE SYMPTOMS NOTED ABOVE. WHILE IT IS POSSIBLE THAT THE PATIENT EXPERIENCED ISSUES RELATED TO THE TITRATION OF REMODULIN, WITH THE INFORMATION PROVIDED IT CANNOT BE RULED OUT THAT A POTENTIAL MALFUNCTION OF THE DEVICE LED TO BRIEF INTERRUPTIONS IN THERAPY, LEADING TO THE HOSPITALIZATION. ALTHOUGH THERE IS NOT A CLEAR CAUSAL LINK BETWEEN THE ISSUES REPORTED AND THE HOSPITALIZATION THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.