BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 21934981 · Received April 30, 2025

    Report

    Report Number
    3016798778-2025-00049
    Event Type
    Malfunction
    Date Received
    April 30, 2025
    Date of Event
    March 9, 2025
    Report Date
    April 30, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY ASSESSED AS NOT MDR REPORTABLE. UPON COMPLETION OF INVESTIGATION OF RETURNED PRODUCT, THE FINDINGS OF THE INVESTIGATION CHANGED THE MDR REPORTABILITY DECISION TO REPORTABLE. MILLYARD CONSIDERS THE DATE THAT THE INVESTIGATION RESULTS WERE FINALIZED (31-MAR-2025) AS ITS AWARENESS DATE.

    Description of Event or Problem · 0

    INFORMATION WAS DISCOVERED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC BY WAY OF A TECHNICAL INVESTIGATION COMPLETED ON 31-MAR-2025. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS INFORMATION IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THE PATIENT REPORTED CASSETTE PROBLEM AND EXCESSIVE NOISE ALARMS ON PUMP S/N (B)(6) WITH REMOTE S/N (B)(6) AND PUMP S/N (B)(6) WITH REMOTE S/N (B)(6). IT WAS ALSO COMMUNICATED THAT THERE WAS DIFFICULTY COMPLETING A SELF-TEST ON BOTH SYSTEMS. THE EXCESSIVE NOISE ALARMS ON PUMP S/N (B)(6) WERE REPORTEDLY RESOLVED WITH BATTERY EXCHANGES. REPLACEMENT SYSTEMS WERE SENT, AND NO ADVERSE SIDE EFFECTS WERE REPORTED. NO CASSETTES WERE RETURNED TO MILLYARD FOR INVESTIGATION. LOGS FROM REMOTE S/N (B)(6) FOR PUMP S/N (B)(6) REVEALED CASSETTE PROBLEM ALARMS INDICATIVE OF A CASSETTE BEING REMOVED DURING STARTUP TESTING. DURING INVESTIGATION, THE PUMP WAS DISASSEMBLED, AND EVIDENCE OF FLUID INGRESS WAS OBSERVED. A TEST DELIVERY COULD NOT BE INITIATED DUE TO THE CONFIRMED INGRESS, CONSISTENT WITH THE REPORTED DIFFICULTY COMPLETING A SELF-TEST. FLUID INGRESS WAS DETERMINED TO BE THE ROOT CAUSE OF THE EVENT. LOGS FROM REMOTE S/N(B)(6) FOR PUMP S/N (B)(6) REVEALED CASSETTE PROBLEM, PUMP ERROR, AND EXCESSIVE NOISE ALARMS INDICATIVE OF A SENSOR ISSUE AND A VALVE LEAK. DURING INVESTIGATION, THE PUMP WAS DISASSEMBLED, AND EVIDENCE OF FLUID INGRESS WAS OBSERVED. A TEST DELIVERY COULD NOT BE INITIATED DUE TO THE CONFIRMED INGRESS, CONSISTENT WITH THE REPORTED DIFFICULTY COMPLETING A SELF-TEST. FLUID INGRESS WAS DETERMINED TO BE THE ROOT CAUSE OF THE EVENT. THE CAUSE OF THE FLUID INGRESS INTO THE PUMPS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THE EVALUATION OF THE RETURNED MATERIAL; HOWEVER, 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
    1182182 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 48 YR Female Hospitalization FAMOTIDINE.| LORATADINE.| MULTI-VITAMIN DAILY TABLET.| OPSUMIT.| TADALAFIL.