BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22667834 · Received July 30, 2025

    Report

    Report Number
    3016798778-2025-00095
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 30, 2025
    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
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AN INITIAL REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 01-JUL-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 02-JUL-2025. THE PATIENT REPORTED THAT SHE STOPPED DRUG INFUSION FOR ABOUT 1 HOUR DUE TO PAIN AT HER INFUSION SITE. THE PATIENT ATTEMPTED TO RESTART INFUSION, BUT HER PUMP INDICATED IT NEEDED ITS BATTERY CHANGED. THE PATIENT REPORTED THAT SHE CHANGED THE BATTERY, BUT HER PUMP WAS STILL NOT WORKING. THE PATIENT ATTEMPTED TO USE HER BACKUP SYSTEM BUT REPORTED THAT THE PUMP WOULD NOT POWER ON. TROUBLESHOOTING WAS UNSUCCESSFUL. THE PATIENT REPORTED THAT SHE HAD NOT BEEN INFUSING DRUG FOR ABOUT 4 HOURS. THE PATIENT WAS HOSPITALIZED TO RECEIVE REMODULIN TREATMENT. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496418 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization ADEMPAS.| OPSUMIT.| PLOGEL-D 0.2%.| TRIAMCINOLONE CREAM.| WINREVAIR.