BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23771647 · Received December 10, 2025

    Report

    Report Number
    3016798778-2025-00143
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 8, 2025
    Report Date
    March 3, 2026
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO MDR #3016798778-2025-00143, ORIGINALLY SUBMITTED ON 10-DEC-2025. THIS SUBMISSION PROVIDES CORRECTIONS TO PREVIOUSLY REPORTED INFORMATION AND INCLUDES THE RESULTS OF THE DEVICE EVALUATION OBTAINED SINCE THE ORIGINAL SUBMISSION. SECTION D4 WAS UPDATED TO INCLUDE THE REMUNITY REMOTE UNIQUE DEVICE INDENTIFICATION (UDI) NUMBERS. THE OCCUPATION (E3) OF THE INITIAL REPORTER WAS INADVERTENTLY LEFT BLANK ON THE ORIGINAL SUBMISSION. FOR CLARIFICATION, THIS SECTION WAS UPDATED TO "OTHER HEALTH CARE PROFESSIONAL". ADDITIONAL IMDRF CODES (H6) WERE ADDED TO REFLECT THE RETURN OF COMPLAINT PRODUCT, LOG FILE REVIEW, AND INVESTIGATION RESULTS. INVESTIGATION PERFORMED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC: LOGS RETRIEVED FROM REMUNITY REMOTE (B)(6) (PAIRED WITH REMUNITY PUMP (B)(6)) AND REMUNITY REMOTE (B)(6) (PAIRED WITH REMUNITY PUMP (B)(6)) SHOWED THAT NO PUMP FAILURE ALARMS HAD OCCURRED. HOWEVER, THE REPORTED EXCESSIVE NOISE AND DELIVERY STOPPED ATTENTION ALARMS WERE CONFIRMED, AS WELL AS SEVERAL PUMP ERROR AND CASSETTE PROBLEM ALARMS. FURTHER REVIEW OF THE LOG DATA ALSO SHOWED INTERMITTENT CONNECTION BETWEEN THE REMOTES AND PUMPS, CONFIRMING THE REPORTED COMMUNICATION ISSUES. DURING THE INVESTIGATION, BOTH REMOTES AND PUMPS WERE TESTED FOR RADIO FREQUENCY POWER AND VALUES WERE FOUND TO BE WITHIN SPECIFICATION. TEST DELIVERIES WERE ALSO ATTEMPTED WITH EACH SYSTEM BUT COULD NOT BE COMPLETED DUE TO ADDITIONAL CASSETTE PROBLEM ALARMS. UPON DISASSEMBLY OF PUMPS (B)(6), EVIDENCE OF FLUID INGRESS WAS OBSERVED, CONSISTENT WITH THE REPORTED AND OBSERVED ALARMS AND COMMUNICATION ISSUES. A SPECIFIC CAUSE FOR THE FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    THE EVENT INFORMATION RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10 NOV 2025 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 11 NOV 2025, WAS INITIALLY ASSESSED AS NON-REPORTABLE. ADDITIONAL INFORMATION LATER RECEIVED FROM CVS SPECIALTY PHARMACY ON 26 NOV 2025 INDICATED THAT IT WAS UNKNOWN IF THE REPORTED PUMP FAILURE ALARMS CORRESPONDED TO THE INITIAL EXCESSIVE NOISE ALARMS AND COMMUNICATION ISSUES OR REPRESENTED SEPARATE EVENTS. BASED ON THE INFORMATION PROVIDED AND THE LACK OF ADDITIONAL DETAILS, THE EVENT WAS UPGRADED TO REPORTABLE ON 26 NOV 2025. THE "DATE RECEIVED BY MANUFACTURER" REFLECTS THE DATE ON WHICH THE EVENT WAS DETERMINED TO MEET REPORTABILITY CRITERIA.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10 NOV 2025 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 11 NOV 2025. IT WAS REPORTED THAT THE PATIENT RECEIVED EXCESSIVE NOISE ALARMS WHILE USING BOTH OF THEIR REMUNITY PUMPS AT A FESTIVAL. AFTER DECLINING THE ALARMS, COMMUNICATION ISSUES OCCURRED BETWEEN THEIR PUMPS AND REMOTE'S, RESULTING IN AN INTERRUPTION IN THERAPY. THE PATIENT REMAINED ASYMPTOMATIC BUT PRESENTED TO THE EMERGENCY ROOM. IT WAS REPORTED THAT ONE OF THE REMOTE'S WAS SUCCESSFULLY RE-PAIRED TO THE CORRESPONDING PUMP; HOWEVER, THE PATIENT DID NOT HAVE EXTRA MEDICATION SUPPLIES OR CASSETTES AND WAS THEREFORE UNABLE TO RESUME INFUSION ON THE DEVICE. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED PUMP FAILURE ALARMS FROM REMUNITY PUMPS, (B)(6) AND (B)(6), AND THEY WERE NO LONGER FUNCTIONING. THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY FOR UP TO ONE HOUR AND WAS PLACED ON THE EMERGENCY ROOM'S REMODULIN SUPPLY. ADDITIONAL INFORMATION RECEIVED FROM CVS SPECIALTY PHARMACY ON 26 NOV 2025 INDICATED THAT IT WAS UNKNOWN IF THE REPORTED PUMP FAILURE ALARMS CORRESPONDED TO THE INITIAL EXCESSIVE NOISE ALARMS AND COMMUNICATION ISSUES OR REPRESENTED SEPARATE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108315 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11094-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other