BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22810619 · Received August 14, 2025

    Report

    Report Number
    3016798778-2025-00098
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 13, 2025
    Report Date
    August 14, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    PMA / PMN Number
    K202690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SITE PAIN WAS REPORTED BY THE PATIENT BUT IS NOT ADDRESSED AS AN ADVERSE EVENT IN THIS REPORT. INFUSION SETS ARE REQUIRED FOR THE USE OF THE REMUNITY PUMP BUT ARE NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR USE WITH THE DEVICE.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 17-JUL-2025 FROM CVS AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 18-JUL-2025 INDICATING THAT THE PATIENT REPORTED RECEIVING COMMUNICATION ALARMS ON (B)(6) 2025. A NURSE ADVISED THE PATIENT TO VERIFY INFUSION, WHICH COULD NOT BE CONFIRMED. THE PATIENT WAS THEN ADVISED TO DETACH AND REATTACH THEIR CURRENT CASSETTE, WHICH RESOLVED THE ISSUE. THE PATIENT REPORTED BEING OUT OF BREATH AT THE TIME OF THE EVENT. THE PATIENT LATER REPORTED SWITCHING THEIR PUMP AND REMOTE ON (B)(6) 2025 FOR AN ANTICIPATED CASSETTE CHANGE BUT RECEIVED THE SAME COMMUNICATION ALARMS AS A FEW DAYS PRIOR. THE PATIENT ALSO REPORTED EXPERIENCING SITE PAIN THAT THEY TREAT WITH CREAMS AND GELS. UPON RETURN TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, LOGS RETRIEVED FROM REMOTE UTRM0016254, PAIRED WITH REMUNITY PUMP UTPM0020490, CONFIRMED A NO COMMUNICATION ATTENTION ALARM ON (B)(6) 2025, APPROXIMATELY 10 HOURS AFTER A DELIVERY HAD BEEN STARTED. DURING INVESTIGATION, A TEST DELIVERY WAS CONDUCTED WITHOUT ISSUE. THE PUMP WAS DISASSEMBLED AND EVIDENCE OF FLUID INGRESS WAS OBSERVED THAT WOULD HAVE CAUSED THE PUMP TO POWER OFF UNEXPECTEDLY, CAUSING THE CONFIRMED NO COMMUNICATION ATTENTION ALARM, AS WELL AS THE INABILITY OF THE PUMP BUTTON TO PRODUCE A NOISE WHEN PRESSED. LOGS RETRIEVED FROM REMOTE UTRM0019828, PAIRED WITH REMUNITY PUMP UTPM0024780, CONFIRMED A NO COMMUNICATION ATTENTION ALARM ON (B)(6) 2025, APPROXIMATELY 10 HOURS AFTER A DELIVERY HAD BEEN STARTED. DURING INVESTIGATION, A TEST DELIVERY WAS CONDUCTED WITHOUT ISSUE. THE PUMP WAS DISASSEMBLED AND EVIDENCE OF FLUID INGRESS WAS OBSERVED THAT WOULD HAVE CAUSED THE PUMP TO POWER OFF UNEXPECTEDLY, CAUSING THE CONFIRMED NO COMMUNICATION ATTENTION ALARM. A SPECIFIC CAUSE FOR THE OBSERVED FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE RETURNED SYSTEMS FUNCTIONED WITHIN SPECIFICATION IN THAT THEY ALARMED PER DESIGN TO ALERT THE USER OF A COMMUNICATION ISSUE AND ENTERED A FAILSAFE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557849 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female C-FORMULATION D W/CLONI 0.2%.| LIDOCAINE/PRILOCAINE CRM.| TRIAMCINOLONE ACET CRM.