BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 21282927 · Received January 31, 2025

    Report

    Report Number
    3016798778-2025-00012
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 3, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    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 THE POTENTIAL FOR HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 06-JAN-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 07-JAN-2025. THE PATIENT REPORTED SHE WAS UNABLE TO TRANSITION BACK TO PREMUNITY THERAPY AFTER SWITCHING TO ANOTHER MANUFACTURER'S DEVICE THAT SHE FELT MORE COMFORTABLE WITH WHILE TRAVELING. THE PATIENT REPORTED THAT ONE REMOTE WOULD NOT POWER ON, AND SHE COULD NOT GET THE BACKUP REMOTE TO PAIR WITH ITS PUMP. TROUBLESHOOTING WAS UNSUCCESSFUL. THE PATIENT REMAINED ON THE OTHER MANUFACTURER'S DEVICE UNTIL REPLACEMENTS WERE SENT AND SUCCESSFULLY TRANSITIONED BACK ON PREMUNITY THERAPY. NO SIDE EFFECTS WERE REPORTED. NO COMPONENTS OR FURTHER INFORMATION ASSOCIATED WITH THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER 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 31-JAN-2025 (REPORT NUMBER: 3016798778-2025-00012). 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. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6) PUMP NOT RETURNED) SHOW THAT THE PUMP AND REMOTE NEVER PERFORMED A DELIVERY AFTER THE DEVICES WERE PAIRED. NO COMMUNICATION ATTENTION AND REMOTE BATTERY LOW ATTENTION ALARMS WERE OBSERVED. THE LOGS ARE CONSISTENT WITH THE PUMP NOT BEING POWERED ON, RATHER THAN A LACK OF COMMUNICATION. SINCE THE PUMP WAS NOT RETURNED, CONNECTIVITY BETWEEN BOTH DEVICES COULD NOT BE TESTED. DURING INVESTIGATION, THE REMOTE WAS PAIRED SUCCESSFULLY WITH AN ENGINEERING PUMP, INDICATING THE REMOTE IS CAPABLE OF PAIRING AND CONNECTING. THE REMOTE'S RF POWER WAS MEASURED TO BE WITHIN SPECIFICATION. THE CAUSE OF THE CONNECTION ISSUES COULD NOT BE INVESTIGATED FURTHER. THE REMOTE BATTERY LOW ATTENTION ALARMS WERE GENERATED DUE TO THE REMOTE BEING REPEATEDLY POWERED ON WHILE THE BATTERY WAS DEPLETED. DURING THE INVESTIGATION, THERE WERE ALSO NO ISSUES CHARGING THE DEVICE, INDICATING THAT THE DEVICE FUNCTIONS NORMALLY. ACCORDING TO THE LOGS, THE REMOTE WAS CHARGED FOLLOWING THE LAST ATTENTION ALARM, INDICATING THAT THE USER CHARGED THE DEVICE WITHOUT ISSUE. THE BATTERY DEPLETION RATE APPEARED NORMAL DURING USE AS WELL. LOGS FROM REMOTE (B)(6) (PAIRED WITH PUMP (B)(6) SHOW NO ABNORMAL ALARMS DURING USE. BEFORE EACH DELIVERY, LOGS SHOW THAT THE SYSTEM STARTED AND COMPLETED SELF-TESTING WITHOUT ISSUE. NO COMMUNICATION ATTENTION ALARMS WERE GENERATED AFTER THE REMOTE HAD BEEN POWERED ON. LOGS INDICATED THE ALARMS WERE GENERATED BECAUSE THE PUMP WAS NEVER POWERED ON, RATHER THAN A LACK OF COMMUNICATION. DURING INVESTIGATION, THE PUMP AND REMOTE PAIRED WITHOUT ISSUE, AND A TEST DELIVERY WAS COMPLETED WITHOUT ABNORMAL BEHAVIOR. THE PUMP AND REMOTE RF POWERS WERE MEASURED TO BE WITHIN SPECIFICATION. DURING INVESTIGATION, PUMP (B)(6) WAS TESTED FOR THE REPORT OF DIFFICULTY ATTACHING CASSETTES. TORQUE WAS MEASURED WITHIN SPECIFICATION IN BOTH DIRECTIONS. NO CASSETTES WERE RETURNED, SO THE COMPLAINT COULD NOT BE INVESTIGATED FURTHER. BOTH SYSTEMS FUNCTIONED WITHIN SPECIFICATION DURING INVESTIGATION AS THEY ALARMED ACCURATELY, AND NO ABNORMAL SYSTEM BEHAVIOR WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519413 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 70 YR Female Hospitalization AMBRISENTAN.| AMBRISENTAN.| CLARITIN.| CLARITIN.| CYMBALTA.| CYMBALTA.| LOPERAMIDE.| LOPERAMIDE.| OXYGEN.| OXYGEN.| PANTOPRAZOLE SODIUM.| PANTOPRAZOLE SODIUM.| PEPCID AC.| PEPCID AC.| PREDNISONE.| PREDNISONE.| SOD CHLORIDE.| SOD CHLORIDE.| TADALAFIL.| TADALAFIL.| TYLENOL EXTRA STRENGTH.| TYLENOL EXTRA STRENGTH.| WINREVAIR.| WINREVAIR.