BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23845890 · Received December 18, 2025

    Report

    Report Number
    3016798778-2025-00146
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 18, 2025
    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

    THE EVENT INFORMATION RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 29-OCT-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 30-OCT-2025 WAS INITIALLY ASSESSED AS NON-REPORTABLE. ADDITIONAL INFORMATION LATER RECEIVED FROM ACCREDO HEALTH GROUP ON 24-NOV-2025 INDICATED THAT THE PATIENT WAS HOSPITALIZED DUE TO THE PRODUCT ISSUE. THE EVENT WAS SUBSEQUENTLY UPGRADED TO REPORTABLE AND THE DATE RECEIVED BY THE MANUFACTURER (G3) FOR MDR PURPOSES IS 24-NOV-2025. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 29-OCT-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 30-OCT-2025. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT RECEIVED A PUMP FAILURE ALARM WHILE USING REMUNITYPRO PUMP, 25050132M, AND THEIR INFUSION WAS SUBSEQUENTLY STOPPED. THE PATIENT SWITCHED TO THEIR BACKUP REMUNITYPRO PUMP, 25050131M, BUT RECEIVED AN ADDITIONAL PUMP FAILURE ALARM ON (B)(6) 2025. REVIEW OF THE SYSTEM'S ALARM HISTORY BY THE PATIENT ALSO REVEALED THAT A NO COMMUNICATION ALARM HAD OCCURRED APPROXIMATELY ONE HOUR INTO THEIR INFUSION. REPORTABLE INFORMATION RELATED TO THIS EVENT WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 21-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 24-NOV-2025. THIS INFORMATION INDICATED THAT THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 AND WAS ADMITTED TO THE HOSPITAL. REPLACEMENT PUMPS WERE SENT TO THE HOSPITAL AND A NURSE PERFORMED AN ONSITE VISIT FOR PATIENT RE-EDUCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239367 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 18 YR Male Hospitalization ADCIRCA.| AMITRIPTYLINE USP.| C-PAP.| CETIRIZINE HCL.| CLONIDINE USP.| ESCITALOPRAM OXALATE.| FAMOTIDINE.| FUROSEMIDE.| GABAPENTINE USP| KETAMINE HCL USP.| KETOPROFEN USP.| LECITHIN.| LIDOCAINE HCL USP.| OPSUMIT.| POLOXAMER GEL.| SOD CHLORIDE.| WINREVAIR.