BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 21893695 · Received April 23, 2025

    Report

    Report Number
    3016798778-2025-00044
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 22, 2025
    Report Date
    April 23, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    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 THE POTENTIAL FOR HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON (B)(6) 2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 25-MAR-2025. THE PATIENT REPORTED THAT HER PUMP WAS ALARMING AND THE REMOTE WOULD NOT TURN ON. TROUBLESHOOTING WAS UNSUCCESSFUL. WITH PHONE SUPPORT, THE PATIENT WAS ABLE TO RESUME INFUSION ON HER BACKUP SYSTEM. THE PATIENT THEN REPORTED HER REMOTE BATTERY WAS LOW AND IT POWERED OFF. THE PATIENT COULD NOT TELL IF SHE WAS STILL INFUSING MEDICATION, AND THEY DISCONNECTED THE CASSETTE. THE SYSTEMS WERE SCHEDULED TO BE REPLACED. NO ADVERSE SIDE EFFECTS WERE REPORTED. 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
    1292153 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 38 YR Female Hospitalization ADEMPAS| OPSUMIT