BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23194578 · Received October 1, 2025

    Report

    Report Number
    3016798778-2025-00120
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    August 12, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    PMA / PMN Number
    K202690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REMUNITY PUMP (B)(6) WAS RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR EVALUATION ON 21-OCT-2025. A TEST DELIVERY WAS PERFORMED WITHOUT ISSUE, AND PUMP (B)(6) FUNCTIONED WITHIN SPECIFICATION. THE REMUNITY REMOTE PAIRED WITH (B)(6), AS WELL AS REMUNITY PUMP (B)(6), WHICH WERE ASSOCIATED WITH THE REPORTED EVENT, WERE NOT RETURNED AND THEREFORE COULD NOT BE EVALUATED FOR THE REPORTED ISSUES. NO FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, TO SUPPORT FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL NOTIFICATION OF AN INTERRUPTION IN THERAPY WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 02-SEP-2025 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON THAT SAME DAY. THE PATIENT REPORTED THAT THE REMUNITY REMOTE PAIRED WITH REMUNITY PUMP (B)(6) WOULD NOT POWER ON. THE PATIENT WAS INSTRUCTED BY ACCREDO ON-CALL SUPPORT TO SWITCH TO THEIR BACKUP REMUNITY PUMP, (B)(6). THE PATIENT ADMITTED TO NOT HAVING USED THEIR BACKUP PUMP FOR SOME TIME AND RECEIVED A PUMP FAILURE ALARM UPON ATTEMPTING TO ATTACH A CASSETTE. ACCORDING TO ACCREDO, IT IS UNKNOWN IF THE PATIENT ATTEMPTED TO PAIR REMUNITY PUMP (B)(6) TO THE REMUNITY REMOTE IN USE WITH REMUNITY PUMP, (B)(6), TO CONTINUE REMODULIN THERAPY. HOWEVER, REPLACEMENT PUMPS WERE ULTIMATELY COURIERED TO THE PATIENT. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277101 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female ALBUTEROL SULFATE HFA.| AMITRIPTYLINE USP.| ATORVASTATIN CALCIUM.| CLONIDINE USP.| FLUTICASONE-SALMETEROL HFA.| GABAPENTIN USP.| JANUVIA.| KETAMINE HCL USP.| KETOPROFEN USP.| LECITHIN.| LIDOCAINE HCL USP.| METFORMIN HCL.| OXYGEN.| POLOXAMER GEL.| SPIRONOLACTONE.| TORSEMIDE.| WINREVAIR.