BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22524184 · Received July 16, 2025

    Report

    Report Number
    3016798778-2025-00083
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 22, 2025
    Report Date
    September 5, 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
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO E1, E2, E3, E4, G2, G7, AND H8.

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS EVENT WAS FILED ON 16-JUL-2025 (REPORT NUMBER 3016798778-2025-00083). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, BY WAY OF A TECHNICAL INVESTIGATION OF RECENTLY RECEIVED MATERIALS COMPLETED ON 29-AUG-2025. UPON RETURN TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 06-AUG-2025, LOGS RETRIEVED FROM REMUNITY REMOTE (B)(6), PAIRED WITH PUMP (B)(6), SHOWED PUMP BATTERY LOW ATTENTION ALARMS. EACH OF THESE ALARMS WAS GENERATED, AS EXPECTED, WHEN AN UNDERCHARGED BATTERY WAS INSTALLED IN THE PUMP. 21 PUMP IDLE ATTENTION ALARMS WERE ALSO CONFIRMED IN THE LOGS, INDICATING THAT DELIVERY WAS SUSPENDED. DELIVERY CAN BE SUSPENDED BY A PUMP ALARM OR BY THE USER STOPPING DELIVERY. THE PUMP IDLE ATTENTION ALARMS WERE GENERATED AS EXPECTED. THE SYSTEM COMPLETED A 72-HOUR TEST DELIVERY WITH NO ABNORMAL BEHAVIOR OR ALARMS. UPON RETURN, LOGS RETRIEVED FROM REMUNITY REMOTE (B)(6), PAIRED WITH PUMP (B)(6), SHOWED 3 PUMP BATTERY LOW ATTENTION ALARMS OVER THE LIFETIME OF THE PUMP. EACH OF THESE ALARMS WAS GENERATED, AS EXPECTED, WHEN AN UNDERCHARGED BATTERY WAS INSTALLED IN THE PUMP. 171 PUMP IDLE ATTENTION ALARMS WERE ALSO CONFIRMED IN THE LOGS BETWEEN (B)(6) 2025, INDICATING THAT DELIVERY WAS SUSPENDED. THE PUMP IDLE ATTENTION ALARMS WERE GENERATED AS EXPECTED. THE SYSTEM COMPLETED A 72-HOUR TEST DELIVERY WITH NO ABNORMAL BEHAVIOR OR ALARMS. BOTH SYSTEMS FUNCTIONED WITHIN SPECIFICATION DURING INVESTIGATION, AS IT ALARMED ACCURATELY AND ENTERED A FAILSAFE STATE.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 3-JUN-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 24-JUN-2025. THE PATIENT REPORTED THAT HER SYSTEM WAS ALARMING INTERMITTENTLY FOR LOW BATTERY, BATTERY DEPLETED, AND PUMP NOT DELIVERING. THE PATIENT REPORTED THAT SHE WAS ABLE TO RESUME INFUSION AFTER EACH INTERRUPTION. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR NAUSEA, VOMITING, AND DIARRHEA. THE CLINICIAN SPECULATED THAT THE PATIENT MAY HAVE INADVERTENTLY BOLUSED HERSELF WITH MEDICATION WHEN RESTARTING INFUSION FOLLOWING AN INTERRUPTION BECAUSE THE PATIENT WAS RESTARTING HER PUMP WHILE STILL BEING CONNECTED TO IT. PATIENTS ARE INSTRUCTED TO DISCONNECT FROM THE PUMP PRIOR TO RESTARTING INFUSION. WHILE THE PATIENT WAS HOSPITALIZED, HER PUMP REPORTEDLY MALFUNCTIONED. THE NATURE OF THE REPORTED MALFUNCTION IS UNKNOWN. TROUBLESHOOTING WAS UNSUCCESSFUL. A REPLACEMENT PUMP WAS SENT TO THE PATIENT SO SHE WOULD HAVE 2 WORKING PUMPS. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600879 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 57 YR Female Hospitalization