BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 21775333 · Received April 4, 2025

    Report

    Report Number
    3016798778-2025-00036
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 4, 2025
    Report Date
    May 1, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    PMA / PMN Number
    K202690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AN INITIAL REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-MAR-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-MAR-2025. ON (B)(6) 2025, A CORRECTIONAL NURSE STATED THAT THE PATIENT'S PUMP WAS CONSTANTLY BEEPING. TROUBLESHOOTING WAS UNSUCCESSFUL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL BECAUSE A BACKUP DEVICE WAS NOT AVAILABLE AT THE JAIL. NO REPORT OF A CLINICAL INJURY, ADVERSE EVENT, OR INTERRUPTION IN THERAPY WERE NOTED. NO COMPONENTS OR FURTHER INFORMATION RELATED TO 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.

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED 04-APR-2025 (REPORT NUMBER 3016798778-2025-00036). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC BY WAY OF A COMPLETED TECHNICAL INVESTIGATION ON RECENTLY RECEIVED MATERIALS THAT WERE IN USE BY THE PATIENT DURING THE REFERENCED EVENT. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6)) SHOW THAT DELIVERY WAS STARTED 1 DAY BEFORE THE DATE OF THE COMPLAINT. A PUMP IDLE ATTENTION ALARM WAS OCCURRING EVERY 15 MINUTES FOR APPROXIMATELY 3.5 HOURS, THIS IS EXPECTED BEHAVIOR. THE DELIVERY WAS ENDED BY THE USER REMOVING THE CASSETTE APPROXIMATELY 1 DAY INTO THE DELIVERY. THE USER FACTORY-RESET THE REMOTE, AND NO FURTHER ATTEMPTS AT RESTARTING A DELIVERY OR RE-PAIRING THE REMOTE AND PUMP WERE MADE. DURING INVESTIGATION, A TEST DELIVERY WAS PERFORMED WHICH ENDED AFTER 72 HOURS IN A CASSETTE DEPLETED ALARM AS EXPECTED. THE REMOTE AND PUMP RF POWER WERE FOUND TO BE WITHIN SPECIFICATION. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6)) SHOW ADJUST PUMP ATTENTION ALARMS WITHIN THE TIMEFRAME OF THE COMPLAINT, WHICH IS CONSISTENT WITH OCCLUSION-LIKE BEHAVIOR. PUMP (B)(6) WAS NOT RETURNED. NO ADDITIONAL MATERIALS WERE RETURNED, SO FURTHER INVESTIGATION INTO THE OCCLUSION ALARMS COULD NOT BE COMPLETED. RETURNED MATERIALS FROM BOTH SYSTEMS FUNCTIONED WITHIN SPECIFICATION AS THEY ALARMED ACCURATELY AND FUNCTIONED AS DESIGNED WITH NO ABNORMAL BEHAVIOR IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302431 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Hospitalization