BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 21586859 · Received March 12, 2025

    Report

    Report Number
    3016798778-2025-00023
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    February 10, 2025
    Report Date
    April 17, 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
    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 11-FEB-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 12-FEB-2025. THE PATIENT REPORTED THAT, FOLLOWING A CASSETTE CHANGE SHE NOTICED REMODULIN HAD LEAKED, AND HER PUMP WOULD NOT WORK. THE PATIENT TRIED TO RESTART INFUSION BUT WAS UNSUCCESSFUL. THE PATIENT TRIED TO SWITCH TO HER BACKUP PUMP BUT IT ALARMED PUMP FAILURE. THE PATIENT REPORTED EXPERIENCING LOW BLOOD PRESSURE, TIREDNESS AND LIGHT-HEADEDNESS. THE PATIENT VISITED THE ER TO RECEIVE A COURIERED SHIPMENT OF REMODULIN AND PUMPS. NO ADMISSION DATES WERE PROVIDED. NO COMPONENTS OR FURTHER INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER 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 12-MAR-2025 (REPORT NUMBER 3016798778-2025-00023). 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 CASSETTE DEPLETED, PUMP ERROR AND PUMP FAILURE ALARMS WERE GENERATED WITHIN THE TIMEFRAME OF THE COMPLAINT. DURING INVESTIGATION, A TEST DELIVERY WAS INITIATED, AND THE SYSTEM GENERATED A CASSETTE DEPLETED ALARM. THE PUMP WAS DISASSEMBLED, AND EVIDENCE OF FLUID INGRESS WAS DETERMINED TO BE THE CAUSE OF THE ALARMS. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6)) SHOW THAT PUMP FAILURE ALARMS WERE GENERATED DURING STARTUP BY THE USER. DURING INVESTIGATION, A TEST DELIVERY WAS INITIATED WITH A PUMP FAILURE ALARM OCCURRING DURING STARTUP. THE PUMP WAS DISASSEMBLED, AND EVIDENCE OF FLUID INGRESS WAS DETERMINED TO BE THE CAUSE OF THE ALARMS. THE CAUSE OF THE FLUID INGRESS IN BOTH PUMPS COULD NOT BE DETERMINED. BOTH SYSTEMS FUNCTIONED WITHIN SPECIFICATION AS THEY ALARMED ACCURATELY AND ENTERED A FAILSAFE STATE AFTER ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112862 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11094-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization OPSUMIT.| OPSUMIT.| TADALAFIL.| TADALAFIL.