BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 20751436 · Received November 21, 2024

    Report

    Report Number
    3016798778-2024-00066
    Event Type
    Death
    Date Received
    November 21, 2024
    Date of Event
    October 30, 2024
    Report Date
    November 21, 2024
    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 REPORT OF HOSPITALIZATION WAS RECEIVED BY (B)(6) ON 31-OCT-2024 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 01-NOV-2024. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 FOR A BRAIN BLEED FROM A CAR ACCIDENT. THE PATIENT WAS SWITCHED TO REMODULIN THERAPY WHILE STILL IN THE HOSPITAL. A PULMONARY FELLOW FROM THE HOSPITAL REPORTED THAT THE PATIENT'S PUMP WOULD NOT CONNECT WITH THE REMOTE. IT WAS ADVISED THAT HOSPITAL EQUIPMENT MAY BE CAUSING INTERFERENCE, AND TROUBLESHOOTING STEPS WERE PROVIDED. THE PULMONARY FELLOW STATED THAT THE PUMP NEEDED TO BE TURNED DOWN [DOSE DECREASED] DUE TO THE PATIENT'S CONDITION. THE PULMONARY FELLOW WAS ADVISED THE PATIENT SHOULD BE TRANSITIONED TO HOSPITAL MEDICATION DUE TO THE NEED TO LOWER THE PRESCRIBED DOSE BELOW THE PUMP'S LOWEST DELIVERY LIMIT. IT IS UNKNOWN IF TROUBLESHOOTING WAS ATTEMPTED OR IF THE PATIENT WAS TRANSITIONED OFF REMODULIN THERAPY. THE PATIENT'S MOTHER AND THE NURSE MANAGER REPORTED THAT THE PATIENT PASSED AWAY IN THE HOSPITAL ON (B)(6) 2024. NO COMPONENTS OR FURTHER INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708018 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death ACETAMINOPHEN| ADCIRCA| B12 ACTIVE| BOSENTAN| DIGOXIN| FLUTICASONE PROP| FUROSEMIDE| MIRENA| OMEPRAZOLE DR| OXYGEN| SOD CHLORIDE| SPIRONOLACTONE| TYVASO| VITAMIN D3