BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22568181 · Received July 22, 2025

    Report

    Report Number
    3016798778-2025-00089
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 22, 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
    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 27-JUN-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 28-JUN-2025. THE PATIENT REPORTED THAT HER PUMP HAD A CRACK IN IT AND HER BACKUP SYSTEM DID NOT WORK AFTER BEING DROPPED IN WATER. THE PATIENT REPORTED THAT SHE WAS NOT FEELING WELL, WITH SYMPTOMS OF LETHARGY, WEAKNESS, SHORTNESS OF BREATH, ELEVATED HEART RATE AND THAT SHE FELT LIKE FAINTING. THE PATIENT WENT TO THE ER, WHERE SHE WAS ADMITTED. REPLACEMENT SYSTEMS WERE SENT. THE NURSE PRACTITIONER REPORTED THAT THE PATIENT DID NOT RECOGNIZE THAT HER PUMP HAD FAILED UNTIL SHE BECAME SYMPTOMATIC WITH SHORTNESS OF BREATH AND SWELLING AFTER 2 DAYS HAD ELAPSED. 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
    1659688 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 31 YR Female Hospitalization AMITRIPTYLINE USP.| CLONIDINE USP.| ELIQUIS.| GABAPENTIN USP.| KETAMINE HCL USP.| KETOPROFEN USP.| LECITHIN.| LEXAPRO.| LIDOCAINE HCL USP.| OPSUMIT.| POLOXAMER GEL.| POTASSIUM CHLORIDE.| SILDENAFIL CITRATE.| TORSEMIDE.| TYLENOL PM EXTRA STRENGTH.