BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24769698 · Received April 2, 2026

    Report

    Report Number
    3016798778-2026-00079
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. SKIN IRRITATION AND PAIN AT THE INFUSION SITE WERE REPORTED BY THE PATIENT, BUT ARE NOT ADDRESSED IN THIS REPORT. INFUSION SETS ARE REQUIRED FOR THE USE OF THE REMUNITY PUMP, BUT ARE NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE DEVICE. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 06-MAR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. IT WAS REPORTED THAT THE PATIENT RECEIVED RECURRING CASSETTE DEPLETED ALARMS WITHIN MINUTES OF CHANGING THE CASSETTES ON BOTH OF THEIR REMUNITY PUMPS. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND SEVERAL PHARMACY-FILLED CASSETTES WERE WASTED. THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY; HOWEVER, THE PATIENT'S CAREGIVER CONFIRMED THAT THEY DID NOT EXPERIENCE ANY WORSENING OF THEIR PULMONARY ARTERIAL HYPERTENSION (PAH) SYMPTOMS. THE PATIENT WAS ADMITTED TO THE HOSPITAL DURING WHICH TIME, THE PATIENT REQUESTED TO BE TRANSITIONED FROM REMUNITY TO A NEW PAH MEDICATION DUE TO THE ISSUES WITH CHANGING THE CASSETTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828504 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11036-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization