MAUDE Adverse Event Report: Millyard Advanced Medical Products, LLC RemunityPRO Pump for Remodulin (treprostinil) Injection; Infusion Pump

Model Number	DKUT-21073-007
Medical Device Problem Codes	Pumping Stopped (1503); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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 received pump failure alarms while using both of their remunitypro pumps, serial numbers (b)(6).The patient experienced an interruption in therapy but denied any adverse side effects.It was further reported that after performing a cassette change for pump (b)(6), the patient was able to restart their infusion; however, they were unable to titrate up to the correct delivery rate as they had forgotten their system passcode.The patient's caregiver later reported that the patient had been admitted to the hospital for evaluation and medical management as they had been off remodulin for an extended period of time.Replacement systems were sent to the patient by the specialty pharmacy.
Additional Manufacturer Narrative
Investigation into the reported event remains ongoing and a supplemental report will be filed once results are available.No additional information relevant to the reported event has been made available to millyard advanced medical products, llc, for further investigation.

• Brand Name: RemunityPRO Pump for Remodulin (treprostinil) Injection
• Common Device Name: Infusion Pump
• Manufacturer (Section D): Millyard Advanced Medical Products, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): Millyard Advanced Medical Products, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer Contact: victoria maroon ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; +1(603)206-0591
• MDR Report Key: 50246125
• Report Number: 3016798778-2026-00266
• Device Sequence Number: 13275794
• Product Code: FRN
• UDI-Device Identifier: 00850017421240
• UDI-Public: (01)00850017421240
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K250357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DKUT-21073-007
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 156 LB