BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23479369 · Received November 5, 2025

    Report

    Report Number
    3016798778-2025-00127
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 4, 2025
    Report Date
    November 5, 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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 06-OCT-2025 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 07-OCT-2025. IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY WITH THE REMUNITY PUMP AND SUBCUTANEOUS SITE PLACEMENT. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER BEING OFF INFUSION FOR APPROXIMATELY ONE HOUR DUE TO UNRESOLVED OCCLUSION ALARMS ON THE REMUNITY PUMP, DESPITE HAVING A FUNCTIONAL BACKUP REMUNITY PUMP. THE PATIENT REFUSED A SUBCUTANEOUS SITE CHANGE AND WAS ULTIMATELY ADMITTED TO THE HOSPITAL FOR INTRAVENOUS REMODULIN THERAPY. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2648577 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 45 YR Male Hospitalization ALBUTEROL SULFATE HFA| AMITRIPTYLINE USP| BENZONATATE| BREZTRI AEROSPHERE| CLONIDINE USP| ELIQUIS| FENOFIBRATE| GABAPENTIN USP| KETAMINE HCL USP| KETOPROFEN USP| LECITHIN| LIDOCAINE HCL USP| MIRTAZAPINE| POLOXAMER GEL| POTASSIUM CHLORIDE| SOD CHLORIDE| TADALAFIL| TORSEMIDE