BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22568169 · Received July 22, 2025

    Report

    Report Number
    3016798778-2025-00088
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 26, 2025
    Report Date
    September 3, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    PMA / PMN Number
    K202690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO B2, E1, E2, E3, E4 AND H8. ADDITIONS TO D4 AND G2.

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED ON 22-JUL-2025 (REPORT NUMBER 3016798778-2025-00088). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, BY WAY OF A TECHNICAL INVESTIGATION OF RECENTLY RECEIVED MATERIALS COMPLETED ON 18-AUG-2025. THE PATIENT REPORTED THAT THE REMUNITY PUMP CAUSED A CASSETTE TO LEAK AND THAT THE BACKUP PUMP COULD NOT BE PAIRED WITH ITS REMOTE. IT WAS REPORTED THAT THE PATIENT WAS TRYING TO PAIR THE BACKUP PUMP WITH A CASSETTE ATTACHED, WHICH IS NOT ADVISED. NO ADVERSE SIDE EFFECTS WERE REPORTED. UPON RETURN TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 04-AUG-2025, LOGS FROM REMUNITY REMOTE (B)(6), PAIRED WITH PUMP (B)(6), SHOWED THAT DATA CUT OUT AFTER A DELIVERY WAS STARTED ON 25-JUN-2025, CONFIRMING A LOSS OF COMMUNICATION. THE REMOTE AND PUMP WERE THEN FACTORY RESET BY THE USER. THIS ATTEMPT TO RE-PAIR THE REMOTE AND PUMP WAS UNSUCCESSFUL. DURING INVESTIGATION, A BATTERY WAS INSERTED INTO THE PUMP, CAUSING CONTINOUS ALARMS. UPON DISASSEMBLY OF THE PUMP, EVIDENCE OF FLUID INGRESS WAS OBSERVED, CONSISTENT WITH THE REPORT OF A CASSETTE LEAK. THE CASSETTE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, A SPECIFIC CAUSE FOR THE LEAK COULD NOT BE DETERMINED. (B)(6) AND (B)(6) FUNCTIONED WITHIN SPECIFICATION UPON RETURN AS THE SYSTEM ALARMED ACCURATELY AND ENTERED A FAILSAFE CONDITION. LOGS FROM REMUNITY REMOTE (B)(6), PAIRED WITH PUMP (B)(6), SHOWED THAT THE PUMP WAS NEVER PAIRED TO THE REMOTE; HOWEVER, BASAL NOT STARTED ATTENTION ALARMS WERE CONFIRMED. THESE ALARMS OCCUR WHEN THE PUMP BUTTON IS PRESSED, BUT DELIVERY CANNOT BE STARTED. THE PUMP AND REMOTE WERE TESTED FOR RADIO FREQUENCY POWER AND WERE FOUND TO BE WITHIN SPECIFICATION. THE DEVICES PAIRED WITHOUT ISSUE DURING INVESTIGATION AND A TEST DELIVERY WAS SUCCESSFULLY PERFORMED. (B)(6) AND (B)(6) FUNCTIONED AS INTENDED DURING INVESTIGATION. A SPECIFIC CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF THE POTENTIAL FOR HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 27-JUN-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 28-JUN-2025. THE PATIENT REPORTED THAT HER PUMP CAUSED A CASSETTE TO LEAK AND THAT SHE COULD NOT PAIR HER BACKUP PUMP WITH ITS REMOTE. IT IS UNKNOWN IF TROUBLESHOOTING WAS ATTEMPTED. THE PATIENT REPORTED A 1.5 HOUR INTERRUPTION IN THERAPY BEFORE A REPLACEMENT SYSTEM ARRIVED THAT WAS USED TO RESTART INFUSION. NO ADVERSE SIDE EFFECTS WERE REPORTED. 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
    1712721 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Hospitalization OPSUMIT