REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

Additional Manufacturer Narrative

EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. INVESTIGATION INTO THE REPORTED EVENT IS CURRENTLY ONGOING. A FOLLOW-UP REPORT CONTAINING THE RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON ITS COMPLETION. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER INVESTIGATION.

Description of Event or Problem

AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 26-MAY-2026 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 27-MAY-2026. IT WAS REPORTED THAT THE PATIENT AWOKE TO A PUMP FAILURE ALARM WHILE USING REMUNITY PUMP, SERIAL NUMBER (B)(6). THE PATIENT SWITCHED TO THEIR BACKUP PUMP AT THE TIME AND CONTINUED THEIR INFUSION. UPON TROUBLESHOOTING WITH A REGISTERED PHARMACIST, THE PATIENT ATTEMPTED TO TURN ON THEIR ORIGINAL PUMP AND PAIR IT TO ITS CORRESPONDING REMOTE, HOWEVER, PAIRING WAS UNSUCCESSFUL AND A "SEARCHING" MESSAGED WAS OBSERVED. THE SPECIALTY PHARMACY PLANNED TO REPLACE THE PUMP. REPORTABLE INFORMATION FROM CVS SPECIALTY PHARAMCY WAS RECEIVED ON 28-MAY-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY REMOTE DISPLAYED A "SEARCHING" MESSAGE AND THEIR PUMP (SERIAL NUMBER (B)(6)) WAS OFF. DESPITE TROUBLESHOOTING EFFORTS, THE PUMP WOULD NOT POWER ON AND THE PATIENT WAS UNSURE HOW LONG THEY HAD BEEN WITHOUT REMODULIN. THE PATIENT FURTHER REPORTED THAT THEY DID NOT HAVE A BACKUP REMUNITY SYSTEM TO USE AS THEY WERE STILL AWAITING A REPLACEMENT SYSTEM AT THE TIME DUE TO THE PREVIOUSLY REPORTED PAIRING ISSUES. THE PATIENT WAS INSTRUCTED TO PRESENT TO THE HOSPITAL BUT REFUSED. IT WAS LATER CONFIRMED THAT THE PATIENT HAD A THIRD REMUNITY SYSTEM ON HAND THAT THEY WERE ABLE TO SWITCH TO AND THE PATIENT RESTARTED THEIR INFUSION WITHOUT ISSUE.