BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 16547588 · Received March 15, 2023

    Report

    Report Number
    3016798778-2023-00008
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 9, 2023
    Report Date
    June 13, 2023
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    PMA / PMN Number
    K190182
    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 15-MAR-2023 (REPORT NUMBER 3016798778-2023-00008). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 01-MAY-2023 BY WAY OF A COMPLETED TECHNICAL INVESTIGATION ON RECENTLY RECEIVED MATERIALS THAT WERE IN USE BY THE PATIENT DURING THE REFERENCED EVENT. INVESTIGATION CONFIRMED THAT STARTING ON THE DAY PRIOR TO THE INITIAL COMPLAINT THROUGH THE DATE OF THE LAST COMPLAINT, THE USER RECEIVED FIVE OCCLUSION ALARMS ON (B)(6), AND WAS NOT ABLE TO SUCCESSFULLY RUN A FULL THERAPY WITHOUT AN ALARM OCCURRING. THE RETURNED PUMP 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 13-FEB-2023 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 14-FEB-2023. THE PATIENT REPORTED RECEIVING AN OCCLUSION ALARM AND NUMEROUS SYMPTOMS SHE ATTRIBUTED TO THE PUMP, SO SHE WENT TO THE HOSPITAL. WHILE AT THE HOSPITAL, THE ALARM WAS RESOLVED WITH TROUBLESHOOTING, AND REMODULIN THERAPY WAS CONTINUED ON HER REMUNITY PUMP. 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
    711210 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization OPSUMIT| OPSUMIT,SILDENAFIL CITRATE| SILDENAFIL CITRATE