BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24742496 · Received March 31, 2026

    Report

    Report Number
    3016798778-2026-00074
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    February 28, 2026
    Report Date
    March 31, 2026
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO HEALTH GROUP, INC. WERE UNSUCCESSFUL. AT THIS TIME, 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 02-MAR-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 03-MAR-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED CASSETTE PROBLEM, PUMP BATTERY LOW, AND CASSETTE DEPLETED ALARMS WHILE USING REMUNITY PUMPS (B)(6) WITH PHARMACY-FILLED AND SELF-FILLED CASSETTES. ADDITIONALLY, THE PATIENT LOST THEIR FIFTH PUMP, (B)(6). THE PATIENT WAS REPORTEDLY WITHOUT REMODULIN FOR 13 HOURS BUT REMAINED ASYMPTOMATIC. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ABLE TO RESTART THEIR THERAPY WITH ONE OF THE PUMPS THEY HAD ON HAND, AND FOLLOWED RETITRATION INSTRUCTIONS FROM THE SPECIALTY PHARMACIST AND THEIR PHYSICIAN. TWO REPLACEMENT REMUNITY SYSTEMS WERE ISSUED TO THE PATIENT BY THE SPECIALITY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803347 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001: DKPI-11036-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female FUROSEMIDE.| GABAPENTIN.| IRON.| OPSUMIT.| PANTOPRAZOLE SODIUM.| TADALAFIL.| TRAMADOL HCL.