BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22196393 · Received June 12, 2025

    Report

    Report Number
    3016798778-2025-00066
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 22, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    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 REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 16-MAY-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-MAY-2025. THE PATIENT REPORTED THAT THE CASSETTE WOULD NOT ATTACH TO EITHER OF HER PUMPS. SHE OBSERVED THE PROBLEM ON ONE PUMP A FEW DAYS AGO BUT DID NOT REPORT IT. SHE IS NOW REPORTING THE ISSUE SINCE SHE HAS NO OTHER BACKUP AND IS NOT ABLE TO CONTINUE REMODULIN THERAPY. NO ADVERSE SIDE EFFECTS WERE REPORTED. REPLACEMENT SYSTEMS WERE BEING SENT BY HER SPECIALTY PHARMACY. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED 12-JUN-2025 (REPORT NUMBER 3016798778-2025-00066). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC BY WAY OF A COMPLETED TECHNICAL INVESTIGATION INTO RECENTLY RECEIVED MATERIALS THAT WERE IN USE BY THE PATIENT DURING THE REFERENCED EVENT. DURING INVESTIGATION, A CASSETTE WAS ABLE TO BE ATTACHED TO PUMP UTPM0019065, AND A TEST DELIVERY WAS COMPLETED WITHOUT ISSUE. THE PUMP WAS DISASSEMBLED WITH NO ABNORMALITIES NOTED. THE SYSTEM MET SPECIFICATION AND FUNCTIONED AS DESIGNED WITH NO ABNORMAL BEHAVIOR OBSERVED. DURING INVESTIGATION, A CASSETTE WAS ABLE TO BE ATTACHED TO PUMP UTPM0019345, AND A TEST DELIVERY WAS COMPLETED WITHOUT ISSUE. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE ELASTOMER GRIPS WERE NOT PRESENT ON THE PUMP, WHICH MAY HAVE CONTRIBUTED TO INCREASED DIFFICULTY ATTACHING AND REMOVING CASSETTES. THE CAUSE OF THE MISSING GRIPS CANNOT BE DETERMINED. THE PUMP WAS DISASSEMBLED, WITH EVIDENCE OF FLUID INGRESS OBSERVED. FLUID INGRESS MAY HAVE CONTRIBUTED TO INCREASED DIFFICULTY ATTACHING AND REMOVING CASSETTES. THE CAUSE OF THE FLUID INGRESS CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805658 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization