BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24257549 · Received February 4, 2026

    Report

    Report Number
    3016798778-2026-00020
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 4, 2026
    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

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT FROM ACCREDO HEALTH GROUP, INC., 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 09-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 10-JAN-2026. IT WAS REPORTED THAT ONE OF THE PATIENT'S REMUNITY PUMPS WAS NOT FUNCTIONING AS EXPECTED, AND THEY WERE ADMITTED TO THE HOSPITAL. NO FURTHER DETAILS REGARDING THE SPECIFIC DEVICE ISSUE WERE PROVIDED. THE PATIENT RECEIVED SUBCUTANEOUS REMODULIN AND REMAINED HOSPITALIZED FROM (B)(6) 2026 UNTIL DISCHARGE ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318737 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 53 YR Female Hospitalization ALBUTEROL HFA| ALBUTEROL SULF INH SOL| AMITRIPTYLINE USP| CITALOPRAM HBR| CLONIDINE USP| FAMOTIDINE| FUROSEMIDE| GABAPENTIN USP| KETAMINE HCL USP| KETOPROFEN USP| LECITHIN| LIDOCAINE HCL USP| LOSARTAN POTASSIUM| OXYGEN| PANTOPRAZOLE SOD DR| POLOXAMER GEL| SYMBICORT