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Remunity DKPI-11042-001Recalls & reported problems

United Therapeutics Corporation · STARTER KIT, PHARMACY FILL, UNIT One starter kit consists of: - (2) Pumps - (2) Remotes - (4) Batteries - (2) Chargers - (4) USB cables - (2) Charger adapters - (1) Quick Reference Guide - (1) User Guide - (2) Belt Clips · Class 2

All models of Remunity (2)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This United Therapeutics Remunity infusion pump has 177 adverse event reports, with 1 death and 13 injuries. The reports mostly describe repeated alarms, lost communication between the pump and its remote, and flow problems, and many reports give little detail. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
177
Deaths reported
1
Injuries reported
14
Recalls naming it
0

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 00850017421035), received between Oct 21, 2021 and Sep 30, 2026 — classified as 1 death, 14 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (90 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 2 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 1 reportsJul 2024: 3 reportsAug 2024: 3 reportsSep 2024: 3 reportsOct 2024: 3 reportsNov 2024: 2 reportsDec 2024: 3 reportsJan 2025: 10 reportsFeb 2025: 4 reportsMar 2025: 8 reportsApr 2025: 11 reportsMay 2025: 11 reportsJun 2025: 12 reportsJul 2025: 16 reportsAug 2025: 3 reportsSep 2025: 7 reportsOct 2025: 2 reportsNov 2025: 7 reportsDec 2025: 8 reportsJan 2026: 9 reportsFeb 2026: 5 reportsMar 2026: 9 reportsApr 2026: 4 reportsMay 2026: 12 reportsJun 2026: 4 reportsJul 2026: 4 reportsAug 2026: 3 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202616
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Insufficient Device Problem Information90
  • Infusion or Flow Problem24
  • Communication or Transmission Problem14
  • Device Contamination with Chemical or Other Material9
  • Wireless Communication Problem9
  • False Alarm8
  • Excess Flow or Over-Infusion7
  • Fluid/Blood Leak7

Patient problems

  • No Clinical Signs, Symptoms or Conditions80
  • Insufficient Information47
  • Dyspnea22
  • Headache13
  • Vomiting10
  • Dizziness9
  • Fatigue8
  • Nausea6

Recent adverse event reports

The 25 most recent of 177 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Infusion or Flow Problem

    Patient problems: Dyspnea; Hypoxia; Low Oxygen Saturation

    MAUDE report 50954806 ↗
  • InjuryAug 28, 2026Unexpected Shutdown

    An initial event notification was received by United Therapeutics Drug Safety on 31-JUL-2026 from (b)(6) , and forwarded to Millyard Advanced Medical Products, LLC, on 01-AUG-2026.The patient reported that their Remunity Pump, serial number (b)(6), would turn off during their infusion without generating any alarms. The patient stated their Remote showed adequate battery life at the time of the events, and they would only notice their infusion had stopped when they began to experience symptoms including shortness of breath, a stomach ache, dizziness, and presyncope when getting up to walk. It was confirmed that the patient had a functional backup system on hand to switch to, and a replacement Remunity system was sent by the (b)(6) Pharmacy.

    Patient problems: Dizziness; Dyspnea; Presyncope

    MAUDE report 50508831 ↗
  • InjuryAug 14, 2026Infusion or Flow Problem

    Patient problems: Swelling/ Edema

    MAUDE report 50256625 ↗
  • MalfunctionAug 7, 2026Insufficient Device Problem Information; Wireless Communication Problem

    An initial event notification was received by United Therapeutics Drug Safety on (b)(6) 2026 from CVS Specialty Pharmacy, and forwarded to Millyard Advanced Medical Products, LLC on (b)(6) 2026. The patient reported that they received an alarm while using one of their Remunity systems, and the Remote displayed the message, "Verify Pump is delivering". Upon silencing the alarm, the patient stated that they were unable to get their Remote out of "searching mode". The patient further reported that their second Pump was not functioning as expected; however, no further information regarding the specific type of device issue was provided. The patient reported that they had recently received RemunityPRO systems and supplies for their planned transition onto the RemunityPRO system. The patient elected to transition to the RemunityPRO Pump early due to the reported issues with their Remunity Pumps.

    Patient problems: Insufficient Information

    MAUDE report 50180975 ↗
  • MalfunctionJul 16, 2026Insufficient Flow or Under Infusion

    Patient problems: Insufficient Information

    MAUDE report 25850730 ↗
  • MalfunctionJul 16, 2026Intermittent Infusion

    Patient problems: Insufficient Information

    MAUDE report 25850725 ↗
  • MalfunctionJul 16, 2026Infusion or Flow Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25850724 ↗
  • MalfunctionJul 9, 2026Crack; Wireless Communication Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25764249 ↗
  • MalfunctionJun 26, 2026Leak/Splash; Infusion or Flow Problem

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-JUN-2026 FROM ACCREDO SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-JUN-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED REPEATED CASSETTE-RELATED ALARMS WHILE USING BOTH OF THEIR REMUNITY PUMPS (SERIAL NUMBERS (B)(6)), AND THEY NOTED THEIR PUMP BATTERIES HAD BEEN WET FOR AN UNKNOWN PERIOD OF TIME. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPERIENCED AND INTERRUPTION IN THERAPY. THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2026 AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. REPLACEMENT REMUNITY SYSTEMS WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY.

    Patient problems: Insufficient Information

    MAUDE report 25641918 ↗
  • MalfunctionJun 25, 2026Insufficient Device Problem Information

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 26-MAY-2026 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 27-MAY-2026. IT WAS REPORTED THAT WHILE PERFORMING A CASSETTE CHANGE AT HOME, THE PATIENT EXPERIENCED ISSUES WITH TWO DIFFERENT REMUNITY USER-FILLED CASSETTES. IT WAS FURTHER REPORTED THAT THE PATIENT'S PUMP AND CASSETTES WERE "DAMAGED". NO FURTHER INFORMATION REGARDING THE REPORTED DEVICE ISSUES WAS PROVIDED. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY AS THEY HAD NO OTHER CASSETTES ON HAND. IT WAS ALSO NOTED THAT THE PATIENT WAS HYPOXIC AND EXPERIENCED LOW BLOOD PRESSURE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS PLACED ON INTRAVENOUS REMODULIN. REPLACEMENT SUPPLIES WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY AND THEY ULTIMATELY RESUMED THERAPY ON THE REMUNITY SYSTEM AND WERE DISCHARGED FROM THE HOPSITAL.

    Patient problems: Hypoxia; Low Blood Pressure/ Hypotension

    MAUDE report 25627229 ↗
  • MalfunctionJun 10, 2026False Alarm

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 11-MAY-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 12-MAY-2026. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT PERFORMED A ROUTINE CASSETTE CHANGE. THE FOLLOWING MORNING, THE PATIENT RECEIVED A PREMATURE CASSETTE DEPLETED ALARM AND SUBSEQUENTLY SWITCHED TO THEIR BACKUP REMUNITY PUMP USING A NEW CASSETTE. LATER THAT SAME DAY, THE PATIENT RECEIVED ANOTHER CASSETTE DEPLETED ALARM. THEY EXCHANGED THE PUMP BATTERY AND RECONNECTED THE SAME CASSETTE; HOWEVER, THE ALARM RETURNED APPROXIMATELY 45 MINUTES LATER. REPLACEMENT PUMPS WERE NOT ISSUED TO THE PATIENT AT THE TIME OF THIS EVENT. ON (B)(6) 2026 THE PATIENT REPORTED THAT THEY CONTINUED TO RECEIVE PREMATURE CASSETTE DEPLETED ALARMS WHILE USING BOTH REMUNITY PUMPS (SERIAL NUMBERS (B)(6) WITH NEW SELF-FILLED CASSETTES. DESPITE THIS, THE PATIENT CONFIRMED THEY WERE ABLE TO CONTINUE THEIR INFUSION ON ONE OF THEIR PUMPS AT THE TIME THE EVENT WAS REPORTED. REPORTABLE INFORMATION WAS RECEIVED ON 19-MAY-2026 BY ACCREDO SPECIALTY PHARMACY, INDICATING THAT THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY DUE T

    Patient problems: Insufficient Information

    MAUDE report 25462921 ↗
  • MalfunctionJun 5, 2026Insufficient Device Problem Information

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 07-MAY-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 08-MAY-2026. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND REQUESTED REMUNITY PUMP REPLACEMENTS. NO INFORMATION WAS PROVIDED REGARDING A SPECIFIC REASON FOR THE HOSPITALIZATION OR TYPE OF DEVICE ISSUE.

    Patient problems: Insufficient Information

    MAUDE report 25416526 ↗
  • MalfunctionMay 29, 2026Insufficient Device Problem Information

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 29-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 30-APR-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMPS WERE NOT FUNCTIONING AS EXPECTED; HOWEVER, INFORMATION REGARDING THE SPECIFIC TYPE OF DEVICE ISSUE WAS NOT PROVIDED. IT WAS ALSO REPORTED THAT THE PATIENT WAS HOSPITALIZED AT THE TIME OF THE EVENT DUE TO DECOMPENSATED PULMONARY ARTERIAL HYPERTENSION RELATED TO COMPLICATIONS FROM PNEUMONIA.

    Patient problems: Insufficient Information

    MAUDE report 25339427 ↗
  • MalfunctionMay 28, 2026Insufficient Device Problem Information

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 28-APR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 29-APR-2026. IT WAS REPORTED THAT, WHILE HOSPITALIZED, THE PATIENT EXPERIENCED AN ISSUE WITH THEIR REMUNITY PUMP RESULTING IN AN INTERRUPTION IN THERAPY FOR APPROXIMATELY 12 HOURS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HYPOXIC AND COULD NOT RECALL THEIR PUMP RATE OR DOSE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE SPECIFIC TYPE OF DEVICE ISSUE OR REASON FOR HOSPITALIZATION.

    Patient problems: Hypoxia

    MAUDE report 25325743 ↗
  • MalfunctionMay 27, 2026Pumping Stopped

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 27-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 28-APR-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMPS (SERIAL NUMBERS (B)(6) AND UTPM (B)(6)) AND THEIR CORRESPONDING REMOTES WOULD TURN OFF INTERMITTENTLY. THE PATIENT'S CAREGIVER FURTHER STATED THAT THE PATIENT WOULD BE UNAWARE OF THIS ISSUE UNTIL HOURS LATER, RESULTING IN INTERRUPTIONS IN THEIR THERAPY. REPLACEMENT SYSTEMS WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY.

    Patient problems: Insufficient Information

    MAUDE report 25306354 ↗
  • MalfunctionMay 22, 2026False Alarm; Leak/Splash

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 24-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 26-APR-2026. IT WAS REPORTED THAT THE PATIENT SLIPPED AND FELL IN WATER. THE PATIENT'S REMUNITY PUMP AND REMOTE BECAME WET, FOLLOWING WHICH, THE SYSTEM STOPPED FUNCTIONING AS EXPECTED AND WOULD CONTINUOUSLY "BEEP" WITH NO MESSAGE ON THE REMOTE SCREEN. THE PATIENT REPORTEDLY HAD A BACKUP REMUNITY SYSTEM; HOWEVER, THEY RECEIVED REPEATED ALARMS TO CHANGE THE CASSETTE, DESITE HAVING ALREADY CHANGED IT. THE PATIENT SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY.

    Patient problems: Insufficient Information

    MAUDE report 25262555 ↗
  • MalfunctionMay 20, 2026Insufficient Device Problem Information; Wireless Communication Problem

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON (B)(6) 2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2026. IT WAS REPORTED THAT THE PATIENT RECEIVED A NO COMMUNICATION ALARM WHILE USING ONE OF THEIR REMUNITY PUMPS, AND THE REMOTE DISPLAYED A "SEARCHING" MESSAGE. TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY. IT WAS FURTHER REPORTED THAT THE PATIENT'S BACKUP REMUNITY SYSTEM WAS NOT FUNCTIONING AS EXPECTED; HOWEVER, NO FURTHER DETAILS REGARDING A SPECIFIC DEVICE ISSUE WERE PROVIDED. IT WAS REPORTED THAT THE PATIENT WAS ULTIMATELY ADMITTED TO THE HOSPITAL AND WOULD BE PLACED ON INTRAVENOUS REMODULIN UNTIL DISCHARGE.

    Patient problems: Insufficient Information

    MAUDE report 25237299 ↗
  • InjuryMay 18, 2026Fluid/Blood Leak

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 18-APR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 21-APR-2026. THE PATIENT'S CAREGIVER REPORTED THAT AT APPROXIMATELY 6:30 AM ON (B)(6) 2026, THE PATIENT'S REMUNITY PUMP WAS ROUTINELY SWITCHED AND THEIR INFUSION WAS RESUMED WITH A NEW CASSETTE AND INFUSION SITE PLACEMENT. A FEW HOURS LATER, WHILE THE PATIENT WAS AT SCHOOL, IT WAS REPORTED THAT THEIR EYES WERE "GLAZED OVER," AND THEY WERE STUMBLING, SLURRING THEIR WORDS, AND HAVING TROUBLE COMPREHENDING. THE PATIENT WAS TAKEN TO A LOCAL HOSPTIAL AND TESTS WERE PERFORMED TO ASSESS FOR POSSIBLE CAUSES OF THE PATIENT'S COGNITIVE IMPAIRMENT. DURING THIS TIME, THE PATIENT'S CAREGIVER REMOVED THE REMUNITY CASSETTE AND SAW THAT MEDICATION FROM THE CASSETTE HAD LEAKED INTO THE PUMP. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY AND WAS RESTARTED ON REMODULIN VIA THEIR BACKUP REMUNITY SYSTEM. THE PATIENT'S CAREGIVER REPORTED THAT THE PATIENT HAD NOTICEABLE IMPROVEMENT SINCE THEN AND WAS DOING MUCH BETTER.

    Patient problems: Cognitive Changes

    MAUDE report 25209783 ↗
  • MalfunctionMay 14, 2026No Audible Alarm; Pumping Stopped

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON (B)(6) 2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMP HAD STOPPED INFUSING. THE PATIENT STATED THAT THEY HAD BEEN UNAWARE THAT THE PUMP HAD STOPPED, AS THE REMOTE HAD NEVER ALARMED, AND SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY. UPON RESTARTING THEIR INFUSION ON THE SAME PUMP AT THEIR FULL DOSE, THE PATIENT EXPERIENCED NAUSEA AND VOMITING AND ULTIMATELY PRESENTED TO THE EMERGENCY ROOM. THE PATIENT WAS GIVEN ANTIEMETIC MEDICATION AND FLUIDS AND WAS SENT HOME. THE PATIENT FURTHER CONFIRMED THAT THEY HAD A FUNCTIONAL BACKUP SYSTEM ON HAND IN ADDITION TO THE SYSTEM IN USE AT THE TIME OF THE EVENT.

    Patient problems: Nausea; Vomiting

    MAUDE report 25179344 ↗
  • MalfunctionMay 12, 2026Insufficient Device Problem Information

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 12-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 14-APR-2026. IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO CHANGE THEIR CASSETTE ON THE MORNING ON (B)(6) 2026 BUT RECEIVED REPEATED ALARMS DESPITE USING BOTH OF THEIR REMUNITY PUMPS (SERIAL NUMBERS: (B)(6). TROUBLESHOOTING EFFORTS WITH MULTIPLE CASSETTES WERE UNSUCCESSFUL AND THE PATIENT SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY. THE PATIENT FURTHER REPORTED THAT THEY HAD AN APPOINTMENT WITH THEIR DOCTOR THE SAME DAY, DURING WHICH TIME THEY WOULD CONFIRM IF THEY SHOULD PRESENT TO THE HOSPITAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25154105 ↗
  • MalfunctionMay 6, 2026Insufficient Device Problem Information

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 06-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 07-APR-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY REMOTES WERE NOT FUNCTIONING AS EXPECTED AND THE PATIENT HAD SUBSEQUENTLY BEEN OFF THEIR MEDICATION FOR APPROXIMATELY TWO TO THREE DAYS. THE PATIENT EXPERIENCED SOME SHORTNESS OF BREATH BUT OTHERWISE FELT "FINE". IT WAS FURTHER REPORTED THAT THE PATIENT WOULD BE TRANSITIONED TO THE REMUNITY PRO SYSTEM.

    Patient problems: Dyspnea

    MAUDE report 25104450 ↗
  • InjuryMay 1, 2026Excess Flow or Over-Infusion

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 02-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 08-APR-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED A CASSETTE DEPLETED ALARM EARLIER THAN EXPECTED WHILE USING REMUNITY PUMP, SERIAL NUMBER (B)(6). THE PATIENT SUBSEQUENTLY SWITCHED TO THEIR BACKUP PUMP, SERIAL NUMBER (B)(6), WITH A NEW CASSETTE. THE FOLLOWING MORNING, THE PATIENT AWOKE FEELING LIGHTHEADED AND EXPERIENCED CHEST DISCOMFORT. THE PATIENT EXPRESSED CONCERN THAT REMUNITY PUMPS WERE INFUSING FASTER THAN THE SET DELIVERY RATE. REPLACEMENT SYSTEMS WERE ISSUED TO THE PATIENT BY THE SPECIALTY PHARMACY.

    Patient problems: Chest Pain

    MAUDE report 25061932 ↗
  • InjuryMay 1, 2026Excess Flow or Over-Infusion

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON (B)(6) 2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2026. IT WAS REPORTED THAT THE PATIENT AWOKE THE MORNING OF (B)(6) 2026 WITH THEIR "HEART RACING, POUNDING HEADACHE, AND SHORTNESS OF BREATH." THE PATIENT EXPRESSED CONCERN THAT THEY RECEIVED EXCESS REMODULIN FROM THEIR REMUNITY PUMP (SERIAL NUMBER(B)(6) AS THEY HAD RECEIVED A CASSETTE DEPLETED ALARM EARLIER THAN EXPECTED. THE PATIENT ELECTED TO PAUSE THEIR INFUSION UNTIL THEIR SYMPTOMS SUBSIDED. A REPLACEMENT SYSTEM WAS ISSUED TO THE PATIENT BY THE SPECIALTY PHARMACY.

    Patient problems: Dyspnea; Headache; Tachycardia

    MAUDE report 25061925 ↗
  • MalfunctionMay 1, 2026Infusion or Flow Problem

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 02-APR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 03-APR-2026. IT WAS REPORTED THAT THREE OF THE PATIENT'S REMUNITY PUMPS (SERIAL NUMBERS (B)(6) WERE NOT FUNCTIONING AS EXPECTED AND THEY RECEIVED RECURRING ALARMS. THE PATIENT REPORTED THAT THEY WERE ABLE TO TEMPORARILY RESOLVE THE ISSUES BY TROUBLESHOOTING, BUT ULTIMATELY SWITCHED TO A FOURTH PUMP THEY HAD ON HAND. THE PATIENT STATED THAT THEY FELT WELL AND DENIED ANY BREATHING ISSUES OR OTHER ADVERSE EVENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25061921 ↗
  • MalfunctionApr 30, 2026Pumping Stopped

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 31-MAR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 01-APR-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALARM DURING THE NIGHT, INSTRUCTING THEM TO CHANGE THEIR CASSETTE. AFTER CHANGING THE CASSETTE, THE PATIENT RECEIVED ADDITIONAL ALARMS AND SUBSEQUENTLY DECIDED TO REMOVE THE BATTERY FROM THE PUMP AND GO BACK TO SLEEP. THE NEXT MORNING, THE PATIENT ATTEMPTED TO CHANGE THEIR CASSETTE AGAIN, BUT THE ALARMS PERSISTED AND THE REMOTE DISPLAYED A MESSAGE TO CHANGE TO THEIR BACKUP PUMP. THE PATIENT REPORTED THAT THEY WERE WITHOUT A BACKUP SYSTEM AS IT HAD BEEN MISPLACED MONTHS PRIOR. THE PATIENT WAS ADVISED TO PRESENT TO THE NEAREST HOSPITAL TO RESTART THEIR INFUSION. INFORMATION WAS LATER RECEIVED FROM CVS SPECIALTY PHARMACY ON (B)(6) 2026 INDICATING THAT THE PATIENT DID NOT PRESENT TO THE HOSPITAL AS INSTRUCTED. IT WAS FURTHER STATED THAT REPLACEMENT PUMPS WERE ISSUED TO THE PATIENT.

    Patient problems: Insufficient Information

    MAUDE report 25049991 ↗

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