BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 18376141 · Received December 21, 2023

    Report

    Report Number
    3016798778-2023-00078
    Event Type
    Injury
    Date Received
    December 21, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    PMA / PMN Number
    K190182
    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 28-NOV-2023 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 29-NOV-2023. THE PATIENT REPORTED THEIR PUMP WAS OFF ALL NIGHT DUE TO AN UNSPECIFIED PUMP ISSUE. THE PATIENT THEN TURNED THEIR PUMP ON IN THE MORNING, CAUSING THEM TO BLACK OUT AND BE HOSPITALIZED FOR FOUR DAYS. WHILE THEY WERE HOSPITALIZED, THEIR PHYSICIAN DECREASED THEIR REMODULIN DOSING. NO COMPONENTS OR ADDITIONAL INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION DESPITE MULTIPLE REQUESTS. 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
    304813 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Hospitalization ADEMPAS.| AMBRISENTAN.