BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24889134 · Received April 15, 2026

    Report

    Report Number
    3016798778-2026-00094
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 15, 2026
    Report Date
    April 15, 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 (B)(6) WERE UNSUCCESSFUL. REDNESS AT THE INFUSION SITE WAS ALSO REPORTED BUT IS NOT ADDRESSED IN THIS REPORT. INFUSION SETS ARE REQUIRED FOR THE USE OF THE REMUNITYPRO PUMP BUT ARE NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE DEVICE. 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 (B)(6) 2026 FROM (B)(6) AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2026. IT WAS REPORTED THAT THE PATIENT RECEIVED A "CASSETTE VOLUME LOW" ALERT EARLIER THAN EXPECTED WHILE USING ONE OF THEIR REMUNITYPRO PUMPS. THE PATIENT ATTEMPTED TO PRIME THEIR TUBING BUT WAS UNABLE TO SEE ANY MEDICATION AND FURTHER TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE PATIENT HAD MISPLACED ONE OF THEIR REMUNITYPRO REMOTES AND SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY AS THEY WERE UNABLE TO RESUME THEIR INFUSION. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED PAIRING ISSUES BETWEEN THEIR REMUNITYPRO PUMPS (SERIAL NUMBERS (B)(6) AND (B)(6)) AND REMOTES AND PRESENTED TO THE EMERGENCY ROOM AFTER BEING WITHOUT REMODULIN FOR APPROXIMATELY SIX HOURS. THE PATIENT DENIED SYMPTOMS OR SIDE EFFECTS DURING THIS TIME. TROUBLESHOOTING EFFORTS BY THE PHYSICIAN AND EMERGENCY ROOM STAFF WERE ULTIMATELY SUCCESSFUL, FOLLOWING WHICH, THE PATIENT WAS ABLE TO RESUME THERAPY ON THEIR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946227 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 64 YR Male Other ACETAMINOPHEN.| COLACE.| CORTEF.| FUROSEMIDE.| GABAPENTIN.| LEVOTHYROXINE SODIUM.| MAALOX ADVANCED.| MELATONIN.| METOPROLOL SUCCINATE.| MULTIVITAMINS TABLET.| PEPCID.| PROCHLORPERAZINE MALEATE.| SILDENAFIL CITRATE.| SPIRONOLACTONE.| SUMATRIPTAN SUCCINATE.| TYLENOL.| VITAMIN D2.| VITAMIN D3.