BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 20207631 · Received September 12, 2024

    Report

    Report Number
    3016798778-2024-00052
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 11, 2024
    Report Date
    October 17, 2024
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    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 REPORT OF THE POTENTIAL OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 13-AUG-2024 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 14-AUG-2024. THE RN FROM THE DOCTOR'S OFFICE REPORTED THAT THE PATIENT HAD A PUMP MALFUNCTION WHICH CAUSED HER TO PASS OUT, BUT SHE WAS DOING WELL AFTER USING HER BACKUP PUMP. THE PATIENT LATER REPORTED TO THE PHARMACY THAT SHE FELT LIKE HER PAH SYMPTOMS WERE WORSE WHEN USING THE PUMP AND THE PUMP DID NOT ALARM BEFORE SHE PASSED OUT. THE PATIENT THOUGHT THE PUMP STOPPED DELIVERING MEDICATION OR WAS DELIVERING TOO LOW OF A DOSE, WHICH LED TO HER PASSING OUT. NO COMPONENTS OR FURTHER INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION DESPITE MULTIPLE REQUESTS.

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED (B)(6) 2024 (REPORT NUMBER. 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. THE REMOTE THAT WAS PAIRED TO PUMP UTPM0012888 WAS NOT RETURNED. PUMP UTPM0012888 WAS CONNECTED TO A DESIGNATED ENGINEERING REMOTE AND LOGS WERE PULLED. LOGS SHOW THAT A FEW DAYS BEFORE THE DATE OF THE COMPLAINT A DELIVERY WAS STARTED WITH UTPM0012888, WHICH CONTINUED FOR APPROXIMATELY 10 HOURS BEFORE IT WAS MANUALLY STOPPED. THE SYSTEM DID NOT GENERATE ANY ALARMS THROUGHOUT THE USAGE. SINCE NO REMOTE WAS RETURNED, NO FURTHER INVESTIGATION IS POSSIBLE INTO THE EVENTS LEADING UP TO THE DATE OF THE COMPLAINT ON THIS PUMP. DURING INVESTIGATION, A TEST DELIVERY WAS RUN USING PUMP UTPM0012888 WITH NO ALARMS GENERATED OVER THE COURSE OF THE DELIVERY. NO FURTHER INVESTIGATION IS POSSIBLE. THE SYSTEM FUNCTIONED WITHIN SPECIFICATION WITH NO ALARMS LOGGED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621991 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization OPSUMIT.| OPSUMIT.| TADALAFIL.| TADALAFIL.| WINREVAIR SDV.| WINREVAIR SDV.