BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24339186 · Received February 13, 2026

    Report

    Report Number
    3016798778-2026-00024
    Event Type
    Death
    Date Received
    February 13, 2026
    Date of Event
    January 14, 2026
    Report Date
    March 5, 2026
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO MDR #3016798778-2026-00024, SUBMITTED ON 13-FEB-2026. THIS SUBMISSION INCLUDES ADDITIONAL INFORMATION OBTAINED SINCE THE ORIGINAL SUBMISSION. ADDITIONAL INFORMATION RECEIVED BY ACCREDO HEALTH GROUP ON 16-FEB-2026 HAS BEEN INCORPORATED INTO THE EVENT NARRATIVE (B5). DESPITE THE NEW INFORMATION, THE PATIENT'S SPECIFIC CAUSE OF DEATH HAS NOT BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE REMUNITY PUMP AND THE PATIENT'S EXPIRATION CANNOT BE DETERMINED. SECTION H6 WAS UPDATED TO REFLECT THAT NO LOG DATA IS AVAILABLE FOR REVIEW. NO COMPONENTS OR FURTHER INFORMATION HAVE BEEN PROVIDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION.

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO HEALTH GROUP, INC., ARE ONGOING. ANY NEW INFORMATION RELEVANT TO THE REPORTED EVENT WILL BE PROVIDED IN A FOLLOW-UP REPORT. IT WAS REPORTED THAT THE PATIENT EXPIRED FOLLOWING A HIP REPLACEMENT PROCEDURE PERFORMED DURING THE HOSPITALIZATION. THE SPECIFIC CAUSE OF DEATH HAS NOT BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE REMUNITY PUMP AND THE PATIENT'S EXPIRATION CANNOT BE DETERMINED. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN PROVIDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 16-JAN-2026 FROM (B)(6) AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-JAN-2026. IT WAS REPORTED THAT ON 14-JAN-2026, THE PATIENT RECEIVED MULTIPLE ALARMS WHILE USING THEIR REMUNITY PUMP. THE PATIENT WAS UNABLE TO RESOLVE THE ALARMS WITH INITIAL TROUBLESHOOTING EFFORTS AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. IT WAS FURTHER REPORTED THAT THE PATIENT PLANNED TO ATTEMPT A CASSETTE CHANGE AND WOULD CONTACT THE SPECIALTY PHARMACY IF ADDITIONAL ASSISTANCE WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON 10-FEB-2026 INDICATED THAT THE PATIENT EXPIRED ON 25-JAN-2026 FOLLOWING A HIP REPLACEMENT PROCEDURE PERFORMED DURING THE HOSPITALIZATION. INFORMATION RECEIVED FROM (B)(6) ON 16-FEB-2026 FURTHER STATED THAT THE PATIENT EXPIRED AFTER HAVING A HIP REPLACEMENT AND BEING HIGH RISK FOR ANESTHESIA DUE TO THEIR EXISTING PULMONARY HYPERTENSION. NO FURTHER DETAILS REGARDING THE SPECIFIC CAUSE OF DEATH WERE PROVIDED.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 16-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-JAN-2026. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT RECEIVED MULTIPLE ALARMS WHILE USING THEIR REMUNITY PUMP. THE PATIENT WAS UNABLE TO RESOLVE THE ALARMS WITH INITIAL TROUBLESHOOTING EFFORTS AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. IT WAS FURTHER REPORTED THAT THE PATIENT PLANNED TO ATTEMPT A CASSETTE CHANGE AND WOULD CONTACT THE SPECIALTY PHARMACY IF ADDITIONAL ASSISTANCE WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED FROM ACCREDO HEALTH GROUP ON 10-FEB-2026 INDICATED THAT THE PATIENT EXPIRED ON (B)(6) 2026 FOLLOWING A HIP REPLACEMENT PROCEDURE PERFORMED DURING THE HOSPITALIZATION. NO FURTHER DETAILS REGARDING THE SPECIFIC CAUSE OF DEATH WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400233 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Hospitalization| D ADEMPAS| CLONAZEPAM| CYMBALTA| DULOXETINE HCL| FUROSEMIDE| IMODIUM A-D| OMEPRAZOLE| OXYGEN| POTASSIUM CHLORIDE| PROBIOTIC| SOD CHLORIDE| SPIRONOLACTONE| VITAMIN C| WARFARIN SODIUM