BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 25262570 · Received May 22, 2026

    Report

    Report Number
    3016798778-2026-00144
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421240
    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 ACCREDO SPECIALTY PHARMACY ARE ONGOING. ANY NEW INFORMATION, RELEVANT TO THE REPORTED EVENT, WILL BE PROVIDED IN A FOLLOW-UP 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 CONTAINING REPORTABLE INFORMATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON (B)(6) 2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON(B)(6) 2026. IT WAS REPORTED THAT THE PATIENT RECEIVED PERSISTENT OCCLUSION ALARMS WHILE USING BOTH OF THEIR REMUNITYPRO PUMPS (SERIAL NUMBERS (B)(6) AND (B)(6). TROUBLESHOOTING EFFORTS, INCLUDING CHANGING THE INFUSION SITE, INFUSION SET TUBING, AND CASSETTES, WERE UNSUCCESSFUL AND THE PATIENT WAS SUBQUENTLY ADMITTED TO THE HOSPITAL ON 21-APR-2026 TO RECEIVE INTRAVENOUS (IV) REMODULIN. INFORMATION LATER RECEIVED FROM ACCREDO SPECIALTY PHARMACY ON (B)(6) 2026, STATED THAT THE PATIENT CONTINUED TO RECEIVE OCCLUSION ALARMS AND WAS READMITTED TO THE HOSPITAL ON (B)(6) 2026. HOWEVER, NO INFORMATION WAS PROVIDED INDICATING A PRIOR DISCHARGE DATE. IT WAS FURTHER REPORTED THAT REPLACEMENT SYSTEMS WERE SENT TO THE PATIENT. UPON RECEIVING THE REPLACEMENT PUMPS, THE PATIENT WAS SWITCHED TO A NEW SYSTEM BUT RECEIVED OCCLUSION AND CASSETTE PROBLEM ALARMS. UPON REMOVING THE CASSETTE DURING ONE OF THESE INSTANCES, THE PATIENT'S CAREGIVER OBSERVED A LARGE AIR BUBBLE IN THE CASSETTE. EDUACATION WAS PROVIDED TO THE CAREGIVER REGARDING PROPER CASSETTE FILL TECHNIQUE. IT WAS FURTHER REPORTED THAT ONE OF THE PATIENT'S REMUNITYPRO PUMPS WAS NOT FUNCTIONING AS EXPECTED AFTER BEING DROPPED BY A MEMBER OF THE HOSPITAL STAFF. TROUBLESHOOTING WAS UNSUCCESSFUL AND THE PATIENT WAS SWITCHED TO A HOSPITAL SUPPLIED SYSTEM WITH A PERIPHERAL IV. NO FURTHER INFORMATION REGARDING A SPECIFIC DEVICE ISSUE WAS PROVIDED. INFORMATION PROVIDED BY ACCREDO SPECIALTY PHARMACY ON (B)(6) 2026 INDICATED THAT THE PATIENT REMAINED HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361623 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-21073-007; DKUT-10006-001 00850017421240

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Hospitalization ADCIRCA| ALENDRONATE SODIUM| AMIODARONE HCL| AMOXICILLIN| CALCIUM + D3| COENZYME Q-10| FAMOTIDINE| FUROSEMIDE| GABAPENTIN| LEVETIRACETAM| LEVOTHYROXINE SODIUM| MAGNESIUM| OXYBUTYNIN CHLORIDE ER| POTASSIUM CL ER| PROBIOTIC| PROTONIX| SOD CHLORIDE| SPIRONOLACTONE| TIZANIDINE HCL| TRAMADOL HCL| VITAMIN C| WINREVAIR| YUTREPIA