BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23534683 · Received November 12, 2025

    Report

    Report Number
    3016798778-2025-00132
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    September 25, 2025
    Report Date
    November 12, 2025
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NOTIFICATION OF A REPORTABLE EVENT THAT OCCURRED ON 25-SEP-2025 WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 17-OCT-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 20-OCT-2025. THE PATIENT'S SPOUSE REPORTED THAT REMUNITY PUMP (B)(6) HAD A PUMP FAILURE ALARM AND REMUNITY PUMP (B)(6) WOULD NOT PAIR. TROUBLESHOOTING WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT'S SPOUSE EXPLAINED THAT THE PATIENT'S NEWEST REMUNITY PUMP, (B)(6), HAD NOT BEEN TAKEN OUT OF THE BOX AND CHARGED YET. THE PATIENT EXPERIENCED LIGHTHEADEDNESS AND WAS INSTRUCTED BY AN ACCREDO HEALTH GROUP REPRESENTATIVE TO GO TO THE EMERGENCY ROOM. REMUNITY PUMPS (B)(6) WERE RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 07-OCT-2025 AND REMAIN UNDER INVESTIGATION. NO FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934459 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 65 YR Male Other ACETAMINOPHEN| ALOE VERA GEL (GRAM)| BUMETANIDE| ELIQUIS| HUMALOG KWIKPEN U-100| JARDIANCE| LANTUS SOLOSTAR| MAGNESIUM OXIDE| METOLAZONE| MIDODRINE HCL| NEURONTIN| ONDANSETRON ODT| OXYGEN| SALINE NASAL SPRAY| SILDENAFIL CITRATE| SOD CHLORIDE| TAMSULOSIN HCL| WINREVAIR