BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24463012 · Received February 26, 2026

    Report

    Report Number
    3016798778-2026-00040
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 26, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421233
    PMA / PMN Number
    K250357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED COLD SYMPTOMS; HOWEVER, NO INFORMATION WAS PROVIDED TO REASONABLY SUGGEST THAT THE PATIENT'S SYMPTOMS WERE RELATED TO THE USE OF THE REMUNITY PRO SYSTEM. THEREFORE, THE PATIENT'S COLD SYMPTOMS WERE NOT INCLUDED IN THIS REPORT. ADDITIONAL INFORMATION PROVIDED BY ACCREDO INDICATED THAT THE PATIENT WAS PRESCRIBED COUGH MEDICINE AND AN ANTIBIOTIC. 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. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE 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 19-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 20-JAN-2026. IT WAS REPORTED THAT FOLLOWING A CASSETTE CHANGE ON (B)(6) 2026, THE PATIENT'S REMUNITYPRO PUMP, SERIAL NUMBER (SN) (B)(6), WOULD NOT START AND THE REMOTE WOULD NOT ADVANCE PAST REPLACE THE BATTERY. THE PATIENT REMOVED THE CASSETTE IN AN ATTEMPT TO RESTART THE PROCESS AND OBSERVED LEAKING FROM THE CASSETTE. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED COMMUNICATION ERROR ALARMS. THE PATIENT RESUMED THEIR INFUSION ON THEIR BACKUP REMUNITYPRO SYSTEM AND A REPLACEMENT SYSTEM WAS ISSUED. INFORMATION RECEIVED ON 20-JAN-2026 FROM ACCREDO HEALTH GROUP, INC. INDICATED THAT ON 19-JAN-2026, A CASSETTE DEPLETED EARLIER THAN EXPECTED WHILE THE PATIENT WAS USING REMUNITYPRO PUMP, SN (B)(6), AND A PUMP ERROR ALARM OCCURRED. UPON REMOVAL OF THE CASSETTE, REMODULIN WAS REPORTEDLY OBSERVED INSIDE THE PUMP. A REPLACEMENT SYSTEM WAS ISSUED. INFORMATION RECEIVED ON 26-JAN-2026 FROM ACCREDO HEALTH GROUP, INC. STATED THAT ON (B)(6) 2026, THE PATIENT SWITCHED TO REMUNITYPRO PUMP, SN (B)(6), WHILE PERFORMING A CASSETTE CHANGE. DURING THIS TIME, REMODULIN REPORTEDLY LEAKED INTO THE PUMP AND THE DEVICE STOPPED WORKING. THE PATIENT ALSO REPORTED RECEIVING A PUMP FAILURE ALARM WHILE USING PUMP, SN (B)(6). REPLACEMENT SYSTEMS WERE ISSUED. THE PATIENT FURTHER REPORTED THAT MEDICATION HAD LEAKED INTO A PUMP THEY HAD RECEIVED ON (B)(6) 2026; HOWEVER, THE SERIAL NUMBER OF THIS PUMP WAS NOT PROVIDED. ON 27-JAN-2026, REPORTABLE INFORMATION WAS RECEIVED FROM ACCREDO HEALTH GROUP, INC. INDICATING THAT THE PATIENT'S SELF-FILLED CASSETTES HAD LEAKED INTO SIX REMUNITYPRO PUMPS IN THEIR POSSESSION. THE PATIENT REPORTED THAT THEIR PUMPS WOULD INITIALLY RUN AFTER FILLING AND PRIMING THE CASSETTES, BUT WOULD ALARM SHORTLY AFTER. UPON CASSETTE REMOVAL, THE INTERIOR OF THE PUMPS WAS REPORTEDLY SATURATED WITH REMODULIN. IT WAS LATER REPORTED THAT ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY OF APPROXIMATELY SEVEN HOURS AFTER RECEIVING PUMP FAILURE ALARMS ASSOCIATED WITH CASSETTE LEAKS INTO REMUNITYPRO PUMPS, SNS (B)(6). REPLACEMENT SYSTEMS, CASSETTES, AND MEDICATION SUPPLIES WERE ISSUED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341023 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-11029-007; DKUT-10008-001; DKUT-10007-001 MM900000007280 00850017421233

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female ACETAZOLAMIDE ER| ALBUTEROL SULFATE HFA| AMITRIPTYLINE USP| CELLCEPT| CLONIDINE USP| CRESTOR| CYCLOBENZAPRINE HCL| DULOXETINE HCL| EMGALITY PEN| GABAPENTIN USP| JARDIANCE| KETAMINE HCL USP| KETOPROFEN USP| LECITHIN| LIDOCAINE HCL USP| METFORMIN ER GASTRIC| OXYGEN| POLOXAMER GEL| PRADAXA| SODIUM BICARBONATE| SPIRIVA RESPIMAT| TADALAFIL| TORSEMIDE| TYLENOL| VITAMIN D2| WIXELA INHUB