BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 16255470 · Received January 27, 2023

    Report

    Report Number
    3016798778-2023-00002
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    December 28, 2022
    Report Date
    November 2, 2023
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    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 MDR REGARDING THIS CASE WAS FILED 27-JAN-2023 (REPORT NUMBER 3016798778-2023-00002). 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 SHOW THAT (B)(6) GENERATED A PUMP FAILURE ALARM ON THE DATE OF THE COMPLAINT. LOGS ALSO SHOW THAT ON THE DATE OF THE COMPLAINT, (B)(6) GENERATED A PUMP ERROR ALARM AND A CASSETTE PROBLEM ALARM. BOTH PUMPS WERE DISASSEMBLED AND THE REPORTED ISSUES WERE ATTRIBUTED TO HARDWARE FAILURES IN EACH PUMP. BOTH PUMPS PERFORMED AS DESIGNED BY ALARMING TO ALERT THE USER OF THE HARDWARE FAILURE.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF PATIENT HOSPITALIZATION WAS MADE TO UNITED THERAPEUTICS ON (B)(6) 2022 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS LLC ON (B)(6) 2022. THE PATIENT'S DAUGHTER REPORTED SHE COULD NOT PAIR HER FATHER'S REMOTE AND PUMP, AND WAS UNABLE TO RESOLVE. THE PATIENT WENT TO THE HOSPITAL TO CONTINUE TO RECEIVE REMODULIN THERAPY. 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
    717486 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization