BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24394024 · Received February 19, 2026

    Report

    Report Number
    3016798778-2026-00032
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 19, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421233
    PMA / PMN Number
    K250357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, IT IS UNCLEAR IF THE PATIENT DID NOT ADEQUATELY SECURE THEIR INFUSION SET TUBING AT THEIR SITE OR AT THE CONNECTION WITH THE CASSETTE. THEREFORE, THIS EVENT IS BEING REPORTED AS A MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. INFUSION SETS ARE REQUIRED FOR THE USE OF THE REMUNITY PRO PUMP, BUT ARE NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE DEVICE. EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT FROMCVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. AT THE TIME OF THIS REPORT, 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 21-JAN-2026 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 22-JAN-2026. IT WAS REPORTED THAT ON 14-JAN-2026, THE PATIENT DID NOT HAVE THEIR INFUSION SET TUBING FULLY SECURED AND MEDICATION LEAKED OUT ONTO THEIR SHIRT DURING THE NIGHT. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED AN OCCLUSION ALARM. THE PATIENT'S CAREGIVER RECONNECTED THE INFUSION USING A NEW CASSETTE. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS INCLUDING CHANGES IN BREATHING, DECREASED BLOOD OXYGEN SATURATION, AND DECREASED BLOOD PRESSURE, AS WELL AS LEG PAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449384 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-11029-007; DKUT-10006-001 00850017421233

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other OPSYNVI