BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22567998 · Received July 22, 2025

    Report

    Report Number
    3016798778-2025-00092
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    October 25, 2024
    Report Date
    July 22, 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

    INFORMATION WAS DISCOVERED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC BY WAY OF A TECHNICAL INVESTIGATION COMPLETED ON 27-JUN-2025. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS INFORMATION IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE PATIENT REPORTED THAT HE WAS HAVING DIFFICULTY ATTACHING AND DETACHING CASSETTES TO BOTH OF HIS PUMPS. REPLACEMENT SYSTEMS WERE SENT. NO INTERRUPTION IN THERAPY OR ADVERSE SIDE EFFECTS WERE REPORTED. DURING INVESTIGATION, PUMPS (B)(6) SHOWED EVIDENCE OF RESIDUE FROM FLUID INGRESS IN THEIR BUTTON SLOTS. A TEST DELIVERY COULD NOT BE PERFORMED ON EITHER SYSTEM AS THE CASSETTES WERE TOO DIFFICULT TO FULLY ATTACH TO THE PUMPS. THE REPORTED ISSUE WAS CONFIRMED. THE CAUSE OF THE FLUID INGRESS CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784562 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 34 YR Male Hospitalization ACETAMINOPHEN.| ADEMPAS.| ASPIRIN EC.| DIGOXIN.| JARDIANCE.| LOPERAMIDE.| OPSUMIT.| POTASSIUM CHLORIDE.| REGLAN.| SPIRONOLACTONE.| TORSEMIDE.| TRAMADOL HCL.