REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

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 WHILE PERFORMING A CASSETTE CHANGE AT HOME, THE PATIENT EXPERIENCED ISSUES WITH TWO DIFFERENT REMUNITY USER-FILLED CASSETTES. IT WAS FURTHER REPORTED THAT THE PATIENT'S PUMP AND CASSETTES WERE "DAMAGED". NO FURTHER INFORMATION REGARDING THE REPORTED DEVICE ISSUES WAS PROVIDED. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY AS THEY HAD NO OTHER CASSETTES ON HAND. IT WAS ALSO NOTED THAT THE PATIENT WAS HYPOXIC AND EXPERIENCED LOW BLOOD PRESSURE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS PLACED ON INTRAVENOUS REMODULIN. REPLACEMENT SUPPLIES WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY AND THEY ULTIMATELY RESUMED THERAPY ON THE REMUNITY SYSTEM AND WERE DISCHARGED FROM THE HOPSITAL.

Additional Manufacturer Narrative

EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY REGARDING THE SPECIFIC DEVICE ISSUES WERE UNSUCCESSFUL. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER INVESTIGATION.