BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 25339433 · Received May 29, 2026

    Report

    Report Number
    3016798778-2026-00164
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    PMA / PMN Number
    K202690
    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 FROM ACCREDO SPECIALTY PHARMACY ARE ONGOING. ANY NEW INFORMATION, RELEVANT TO THE REPORTED EVENT, WILL BE PROVIDED IN A FOLLOW-UP REPORT. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 30-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 02-MAY-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED CASSETTE PROBLEM ALARMS WHILE USING REMUNITY PUMPS, SERIAL NUMBERS (B)(6) AND (B)(6). IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED COMMUNICATION ISSUES BETWEEN THESE PUMPS AND THEIR CORRESPONDING REMOTES. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT WAS URGED TO PRESENT TO THE HOSPITAL WHILE AWAITING REPLACEMENT SYSTEMS FROM THE SPECIALTY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212313 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001; DKPI-11036-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1