BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22331696 · Received June 25, 2025

    Report

    Report Number
    3016798778-2025-00072
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 25, 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 HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 29-MAY-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 30-MAY-2025. THE NURSE FROM THE DOCTOR'S OFFICE REPORTED THAT THE PATIENT WAS ADMITTED DUE TO PUMP ISSUES. IT WAS PREVIOUSLY PLANNED FOR A SPECIALTY PHARMACY CLINICIAN TO EVALUATE THE PATIENT'S ABILITY TO SELF-ADMINISTER, BUT THE EVALUATION DID NOT OCCUR IN PERSON AND WAS FACILITATED VIRTUALLY. THE PATIENT REPORTED THAT SHE WAS IN THE HOSPITAL DUE TO BOTH PUMPS MALFUNCTIONING. THE DOCTOR SAW THE PATIENT EARLIER THAT MORNING AND THE PATIENT REPORTED THAT SHE WAS UNABLE TO PRIME THE CASSETTE OR PAIR HER PUMP AND REMOTE. TROUBLESHOOTING DID NOT OCCUR, AND NO ADVERSE SIDE EFFECTS WERE REPORTED. THE PATIENT LATER REPORTED THAT SHE WAS TOO WEAK TO TURN THE CASSETTE AND NEEDED TO BE TRANSITIONED TO IV REMODULIN. 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
    1141810 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 54 YR Female Hospitalization SILDENAFIL| WINREVAIR