BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23077306 · Received September 17, 2025

    Report

    Report Number
    3016798778-2025-00113
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    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

    INFUSION SITE PAIN AND DISCOMFORT WERE REPORTED BY THE PATIENT, BUT ARE NOT ADDRESSED 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. NO REMUNITY PUMPS OR CASSETTES WERE RETURNED FOR INVESTIGATION TO RULE OUT CONTRIBUTION TO THE REPORTED EVENT; HOWEVER, AN ISSUE WITH THE INFUSION SET OR AT THE INFUSION SITE COULD ALSO HAVE LED TO THE REPORTED REMUNITY ALARMS.

    Additional Manufacturer Narrative · 0

    INFUSION SITE PAIN AND DISCOMFORT WERE REPORTED BY THE PATIENT, BUT ARE NOT ADDRESSED 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 18-AUG-2025 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 19-AUG-2025. THE PATIENT'S SPOUSE REPORTED THAT REMUNITY PUMP (B)(6) ALARMED TO DISCONNECT FROM THE PUMP. AFTER TROUBLESHOOTING AND RESTARTING THE PUMP, A CASSETTE PROBLEM ALARM WAS RECEIVED. THE PATIENT WAS WITHOUT REMODULIN FOR APPROXIMATELY 1.5 HOURS. IT WAS LATER REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 DUE TO THE EVENT AND WAS ULTIMATELY TRANSITIONED OFF REMODULIN. REMUNITY REMOTES (B)(6) WERE RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR INVESTIGATION ON 01-OCT-2025. LOGS RETRIEVED FROM REMUNITY REMOTE (B)(6), PAIRED WITH REMUNITY PUMP (B)(6), CONFIRMED OCCLUSION-LIKE BEHAVIOR RESULTING IN AN OCCLUSION ALARM AND AN ADJUST PUMP ATTENTION ALARM BETWEEN (B)(6) 2025. A SPECIFIC CAUSE FOR THE OCCLUSION-LIKE BEHAVIOR COULD NOT BE DETERMINED. LOGS RETRIEVED FROM REMUNITY REMOTE (B)(6), PAIRED WITH REMUNITY PUMP (B)(6), CONFIRMED OCCLUSION-LIKE BEHAVIOR RESULTING IN OCCLUSION AND ADJUST PUMP ATTENTION ALARMS. CASSETTE PROBLEM AND PUMP ERROR ALARMS WERE ALSO GENERATED BETWEEN (B)(6) 2025. A SPECIFIC CAUSE FOR THESE ALARMS COULD NOT BE DETERMINED. THE RETURNED REMUNITY REMOTES FUNCTIONED WITHIN SPECIFICATION DURING INVESTIGATION. NO OTHER COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 18-AUG-2025 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 19-AUG-2025. THE PATIENT'S SPOUSE REPORTED THAT REMUNITY PUMP (B)(6) ALARMED TO DISCONNECT FROM THE PUMP. AFTER TROUBLESHOOTING AND RESTARTING THE PUMP, A CASSETTE PROBLEM ALARM WAS RECEIVED. THE PATIENT WAS WITHOUT REMODULIN FOR APPROXIMATELY 1.5 HOURS. IT WAS LATER REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2025 DUE TO THE EVENT AND WAS ULTIMATELY TRANSITIONED OFF REMODULIN. 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
    1635641 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization ALPRAZOLAM.| AMLODIPINE BESYLATE.| CALCIUM + D3.| ESCITALOPRAM OXALATE.| LEVOTHYROXINE SODIUM.| METOPROLOL SUCCINATE.| PRAMIPEXOLE DIHYDROCHLORIDE.| ROSUVASTATIN CALCIUM.| SOD CHLORIDE.| VITAMIN B-12.| WINREVAIR.