BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 17913930 · Received October 11, 2023

    Report

    Report Number
    3016798778-2023-00053
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 11, 2023
    Report Date
    February 15, 2024
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    PMA / PMN Number
    K190182
    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 MDR REGARDING THIS CASE WAS FILED 11-OCT-2023 (REPORT NUMBER 3016798778-2023-00053). 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 THE SYSTEM GENERATED OCCLUSION AND CASSETTE PROBLEM ALARMS. DURING INVESTIGATION, PUMP (B)(6) WAS ATTACHED TO A SOAP-WATER CASSETTE AND DELIVERY RAN FOR 24 HOURS WITH NO ALARMS GENERATED BEFORE BEING MANUALLY STOPPED. THE PUMP WAS DISASSEMBLED FOR FURTHER INVESTIGATION AND FLUID INGRESS WAS IDENTIFIED. THE FLUID INGRESS DID NOT PERMANENTLY DAMAGE THE PUMP, BUT MAY HAVE CAUSED THE REPORTED ALARMS. NO CASSETTES OR INFUSION SETS WERE RETURNED. NO FURTHER INVESTIGATION IS POSSIBLE INTO THE CAUSE OF THE FLUID INGRESS. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6) SHOW THAT THE SYSTEM GENERATED OCCLUSION, CASSETTE PROBLEM, AND PUMP ERROR ALARMS LEADING UP TO THE DATE OF THE COMPLAINT. LOGS FURTHER SHOW THAT THE DAY AFTER THE COMPLAINT, A SUCCESSFUL THERAPY WAS RUN ON THIS SYSTEM WITH NO ALARMS GENERATED. THIS INDICATES THE SYSTEM WAS FUNCTIONING AS DESIGNED. NO CASSETTES OR INFUSION SETS WERE RETURNED, AND PUMP (B)(6) WAS NOT RETURNED. NO FURTHER INVESTIGATION IS POSSIBLE INTO THE CAUSE OF THE ALARMS. ALL SYSTEMS WERE OBSERVED TO HAVE APPROPRIATELY ALARMED AS DESIGNED.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF POTENTIAL PATIENT HOSPITALIZATION WAS RECEIVED BY (B)(6) ON 2023 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 13-SEP-2023. THE PATIENT REPORTED BOTH PUMPS HAD MALFUNCTIONED, IT IS UNKNOWN IF TROUBLESHOOTING WAS ATTEMPTED. THE PATIENT WAS ADVISED TO GO TO THE HOSPITAL. NO SIDE EFFECTS WERE REPORTED. NO COMPONENTS OR ADDITIONAL INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION DESPITE MULTIPLE REQUESTS. 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
    1970532 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female