BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24769697 · Received April 2, 2026

    Report

    Report Number
    3016798778-2026-00080
    Event Type
    Death
    Date Received
    April 2, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421233
    PMA / PMN Number
    K250357
    Adverse Event
    Yes
    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. ARE ONGOING. ANY NEW INFORMATION RELEVANT TO THE EVENT WILL BE PROVIDED IN A FOLLOW-UP REPORT. PATIENTS ARE FURNISHED WITH A BACKUP REMUNITYPRO SYSTEM TO ENSURE UNINTERRUPTED DRUG DELIVERY; HOWEVER, BASED ON THE INFORMATION AVAILABLE, IT IS UNKNOWN IF THE PATIENT WAS ABLE TO SWITCH TO THEIR BACKUP SYSTEM AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PATIENT EXPIRED WHILE IN THE HOSPITAL. THE SPECIFIC CAUSE OF DEATH HAS NOT BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE REMUNITYPRO PUMP AND THE PATIENT'S EXPIRATION CANNOT BE DETERMINED. 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 06-MAR-2026 FROM (B)(6), INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 07-MAR-2026. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO COMMUNICATION ISSUES BETWEEN THEIR REMUNITY PRO PUMP AND REMOTE AND THEIR PUMP BEING IDLE. IT WAS LATER REPORTED THAT WHILE IN THE HOSPITAL, THE PATIENT EXPIRED ON (B)(6) 2026. NO INFORMATION REGARDING THE SPECIFIC CAUSE OF DEATH WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828494 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-11029-007 00850017421233

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death| H ADEMPAS| AMBRISENTAN| B COMPLEX TABLET| LATANOPROST| MIDODRINE HCL| OXYGEN