BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 21808918 · Received April 9, 2025

    Report

    Report Number
    3016798778-2025-00037
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 9, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    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 10-MAR-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 11-MAR-2025. THE PATIENT REPORTED THEIR PUMP ALARMED FOR ERROR AND THAT THE REMOTE WOULD NOT TURN ON WHILE PLUGGED IN. THEY STATED THEIR BACKUP PUMP HAS BEEN BROKEN SINCE (B)(6) 2024 BUT SHE NEVER REPORTED IT. THE PATIENT WAS OFF MEDICATION FOR ABOUT 1 HOUR AT THE TIME OF THE REPORT AND STATED SHE FEELS FINE. REPLACEMENT SYSTEMS WERE SENT. NO COMPONENTS OR FURTHER INFORMATION RELATED TO 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
    1454458 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Hospitalization ACETAMINOPHEN.| AMITRIPTYLINE USP.| CLONIDINE USP.| EPIPEN.| GABAPENTIN USP.| KETAMINE HCL USP.| KETOPROFEN USP.| LECITHIN.| LIDOCAINE HCL USP.| NORETHINDRONE.| OXYGEN.| POLOXAMER GEL.