BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 21979588 · Received May 7, 2025

    Report

    Report Number
    3016798778-2025-00053
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 5, 2025
    Report Date
    July 9, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    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 HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 07-APR-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 08-APR-2025. THE PATIENT REPORTED THAT HER PUMP WAS RUNNING THE PREVIOUS NIGHT AROUND 2200, BUT IT WAS NOT RUNNING WHEN SHE WOKE UP AT 1000. SHE REPORTED SHE WAS HAVING CHEST PAIN AND DIFFICULTY BREATHING. HER REMOTE HAD BEEN LYING UNDER A HEATING PAD SINCE LAST NIGHT AND WOULD NOT POWER ON. THE PATIENT RESTARTED THERAPY ON HER BACKUP PUMP AND HER DIFFICULTY BREATHING RESOLVED, BUT SHE CONTINUED TO HAVE CHEST PAIN AND WENT TO THE ER. 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 07-MAY-2025 (REPORT NUMBER 3016798778-2025-00053). 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. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6) SHOW THAT REMOTE BATTERY LOW ATTENTION ALARMS WERE GENERATED ON THE DATE OF THE COMPLAINT. THE REMOTE BATTERY CHARGE WAS 0% AT THE TIME OF THESE ALARMS. THE BATTERY DEPLETED AT AN INCREASED RATE PRIOR TO THESE ALARMS, AND THE REMOTE BATTERY TEMPERATURE INCREASED TO 47°C. THIS IS ATTRIBUTED TO THE REMOTE REPORTEDLY BEING FOUND UNDER A HEATING PAD. THE REMOTE BATTERY CHARGE DEPLETED AT AN EXPECTED RATE DURING ALL OTHER DELIVERIES. THE LOGS ALSO SHOW THAT THE PUMP WAS RUNNING WITHOUT ISSUE DURING THIS TIME. DELIVERY WAS STOPPED WHEN THE CASSETTE WAS REMOVED AFTER 23 HOURS OF DELIVERY. DURING INVESTIGATION, A TEST DELIVERY WAS PERFORMED, AND NO ABNORMAL BEHAVIOR WAS OBSERVED. THE REMOTE WAS DISASSEMBLED AND NO COMPONENT DAMAGE WAS OBSERVED. THE SYSTEM MET SPECIFICATIONS AND FUNCTIONED AS EXPECTED DURING INVESTIGATION. NO SYSTEM ISSUES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144409 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 28 YR Female Hospitalization ALBUTEROL SULFATE HFA| ALBUTEROL SULFATE HFA| AMITRIPTYLINE USP| AMITRIPTYLINE USP| AMLODIPINE BESYLATE| AMLODIPINE BESYLATE| CLONIDINE USP| CLONIDINE USP| CYANOCOBALAMIN INJECTION| CYANOCOBALAMIN INJECTION| FUROSEMIDE| FUROSEMIDE| GABAPENTIN USP| GABAPENTIN USP| KETAMINE HCL USP| KETAMINE HCL USP| KETOPROFEN USP| KETOPROFEN USP| LECITHIN| LECITHIN| LEVALBUTEROL HCL| LEVALBUTEROL HCL| LIDOCAINE HCL USP| LIDOCAINE HCL USP| ONDANSETRON HCL| ONDANSETRON HCL| OXYGEN| OXYGEN| POLOXAMER GEL| POLOXAMER GEL| SILDENAFIL CITRATE| SILDENAFIL CITRATE| SOD CHLORIDE| SOD CHLORIDE| SPIRONOLACTONE| SPIRONOLACTONE| STOOL SOFTENER| STOOL SOFTENER| SYMBICORT| SYMBICORT| TYLENOL| TYLENOL| UPTRAVI| UPTRAVI| XOPENEX| XOPENEX