REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

Description of Event or Problem

AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 03-JUN-2026 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 04-JUN-2026. IT WAS REPORTED THAT THE TUBING ON THE PATIENT'S REMUNITY CASSETTE HAD "BROKEN" AND THEY LOST REMODULIN OVERNIGHT. THE PATIENT FURTHER REPORTED THAT THIS ISSUE HAD OCCURRED 2-3 TIMES PRIOR, ALWAYS AT NIGHT WHILE THEY WERE SLEEPING. THE PATIENT CHANGED THE CASSETTES TO RESOLVE THE ISSUE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED TUBING "BREAKS" WITH PREVIOUS CASSETTES; HOWEVER, THE DATES OF THOSE OCCURRENCES WERE NOT PROVIDED. THEREFORE, THE DATE OF THE EVENT (SECTION B3) WAS LEFT BLANK. EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO SPECIALTY PHARMACY REMAIN ONGOING. ANY NEW INFORMATION, RELEVANT TO THE REPORTED EVENT, WILL BE PROVIDED IN A FOLLOW-UP REPORT. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER INVESTIGATION.