MAUDE Adverse Event Report: MILLYARD ADVANCED MEDICAL PRODUCTS, LLC REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION; INFUSION PUMP

Model Number	DKPI-11036-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 29-jan-2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc on 30-jan-2026.It was reported that the patient's cassette broke when their remunity pump fell.The patient did not have any more cassettes available and experienced an interruption in therapy.It was later reported that the patient was hospitalized and restarted on remodulin from the hospital's supply.
Additional Manufacturer Narrative
Efforts to obtain additional information from cvs specialty pharmacy 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.

• Brand Name: REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial 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. commericial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 24470735
• Report Number: 3016798778-2026-00041
• Device Sequence Number: 9644301
• Product Code: QJY
• UDI-Device Identifier: 00850017421073
• UDI-Public: (01)00850017421073
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202690
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: DKPI-11036-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADEMPAS; OPSUMIT; WINREVAIR SDV
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 27 YR
• Patient Sex: Female