REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

Description of Event or Problem

AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-JUN-2026 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-JUN-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED REPEATED CASSETTE-RELATED ALARMS WHILE USING BOTH OF THEIR REMUNITY PUMPS (SERIAL NUMBERS (B)(6)), AND THEY NOTED THEIR PUMP BATTERIES HAD BEEN WET FOR AN UNKNOWN PERIOD OF TIME. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPERIENCED AND INTERRUPTION IN THERAPY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2026 AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. REPLACEMENT REMUNITY SYSTEMS WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY.

Additional Manufacturer Narrative

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.