BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 16325504 · Received February 8, 2023

    Report

    Report Number
    3016798778-2023-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Report Date
    April 14, 2023
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    PMA / PMN Number
    K202690
    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 08-FEB-2023 (REPORT NUMBER 3016798778-2023-00003). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 24-FEB-2023 BY WAY OF A COMPLETED TECHNICAL INVESTIGATION ON RECENTLY RECEIVED MATERIALS THAT WERE IN USE BY THE PATIENT DURING THE REFERENCED EVENT. INVESTIGATION OF THE RETURNED MATERIALS CONFIRMS THAT ON THE DATE OF THE COMPLAINT (06-JAN-2023), THE USER RECEIVED AN OCCLUSION ALARM ON PUMP UTPM0006602. LOG BEHAVIOR LEADING UP TO THE OCCLUSION ALARM IS CONSISTENT WITH AN OCCLUSION. THIS BEHAVIOR COULD NOT BE RECREATED DURING INVESTIGATION USING RETURNED MATERIALS AND KNOWN GOOD INFUSION SET. SINCE NO CASSETTES OR INFUSION SETS WERE RETURNED, THE CAUSE OF THE OCCLUSION ALARMS COULD NOT BE DETERMINED. BOTH PUMPS MET SPECIFICATION AND OPERATED AS DESIGNED WHEN TESTED.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF PATIENT HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS ON 09-JAN-2023 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS LLC ON 10-JAN-2023. THE PATIENT REPORTED SHE HAD A DISCONNECTION ISSUE WITH ONE PUMP, AND THEN AN OCCLUSION ALARM WITH HER SECOND PUMP. SHE WAS UNABLE TO RESOLVE EITHER REPORTED ISSUE. THE PATIENT WENT TO THE HOSPITAL TO CONTINUE TO RECEIVE REMODULIN THERAPY UNTIL REPLACEMENT PUMPS WERE RECEIVED. 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
    2309553 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Hospitalization