BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24987349 · Received April 24, 2026

    Report

    Report Number
    3016798778-2026-00103
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 24, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421219
    PMA / PMN Number
    K250357
    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 ACCREDO SPECIALTY PHARMACY ARE ONGOING. IT WAS REPORTED THAT THE PATIENT WAS UTILIZING A 25 GAUGE X 3/8 INCH NEEDLE TO FILL THEIR CASSETTES. PER VERSION 1.9 OF THE REMUNITY PRO USER GUIDE, AVAILABLE AT THE TIME OF THE EVENT, PATIENTS ARE ADVISED THAT ONLY 27 GAUGE X 3/8 INCH OR 26 GAUGE X 3/8 INCH NEEDLES ARE APPROVED FOR FILLING THE REMUNITY PRO CASSETTES. THE USER GUIDE FURTHER CAUTIONS PATIENTS THAT SUPPLIES PROVIDED WITH PREVIOUS VERSIONS OF THE REMUNITY SYSTEM ARE NOT COMPATIBLE WITH THE REMUNITY PRO SYSTEM. THIS GUIDE ALSO PROVIDES THE STEPS TO ENSURE PROPER TECHNIQUE WHEN FILLED CASSETTES. THE NEEDLES ARE REQUIRED FOR THE USE OF THE REMUNITY PRO 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 25-MAR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 26-MAR-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALARM AFTER FILLING THE CASSETTE ON REMUNITY PRO PUMP, SERIAL NUMBER (SN) (B)(6). UPON REMOVING THE CASSETTE, MEDICATION LEAKED INTO THE BOTTOM OF THE PUMP AND INTO THE BATTERY COMPARTMENT, AFTER WHICH, THE PUMP WOULD NOT POWER ON OR MAKE ANY SOUNDS, AND THE REMOTE DISPLAYED A "NO COMMUNICATION" MESSAGE. IT WAS ALSO REPORTED THAT THE PATIENT'S TWO PREVIOUS CASSETTES HAD LEAKED. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED ADDITIONAL CASSETTE LEAKS RESULTING IN DAMAGE TO THE PUMPS, WHILE USING REMUNITY PRO PUMPS, SNS (B)(6). THE PATIENT SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY FOR APPROXIMATELY 12 HOURS. UPON TROUBLESHOOTING, IT WAS DISCOVERED THAT THE PATIENT WAS UTILIZING THE INCORRECT SIZE NEEDLE TO FILL THE CASSETTES. THE PATIENT WAS ADVISED TO REMOVE AND DISCARD ALL OF THE INCORRECTLY SIZED NEEDLES FROM THEIR SUPPLY. THE PATIENT REPORTED THAT THEY HAD ONE PUMP ON HAND THAT HAD NOT BEEN DAMAGED. THE PATIENT SUCCESSFULLY FILLED A NEW CASSETTE AND RESUMED THEIR INFUSION WITHOUT FURTHER ALARMS. REPLACEMENT PUMPS AND BATTERY KITS WERE ISSUED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299939 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-10006-001; DKUT-21073-007 00850017421219

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female ACETAMINOPHEN ER| ADCIRCA| AMITRIPTYLINE USP| ASPIRIN EC| ATORVASTATIN CALCIUM| BACLOFEN| CELECOXIB| CLONIDINE USP| DILTIAZEM| DULOXETINE HCL| FLUTICASONE PROPIONATE| GABAPENTIN| GABAPENTIN USP| JARDIANCE| KETAMINE HCL USP| KETOPROFEN USP| LECITHIN| LEVONORGESTREL| LIDOCAINE HCL USP| LORAZEPAM| LOSARTAN-HYDROCHLORITHIAZIDE| METFORMIN HCL| OPSUMIT| POLOXAMER GEL| POTASSIUM CHLORIDE| PROTONIX| SERTRALINE HCL| SOD CHLORIDE| TADALAFIL| TORSEMIDE