MAUDE Adverse Event Report: KORU MEDICAL SYSTEMS FREEDOM60®; FREEDOM60 INFUSION PUMP

Model Number	F10050-A
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of mw5176493 received through the fda medwatch program stating "patient's mom reporting freedom pump broke.During infusion, the pump shot syringe filled with hizentra out of the pump.Sending pt new freedom pump to replace the broken one.Pt had old pump and was able to complete infusion with that.Pump expiration date: 2026-02-26 serial number (b)(6).Pump start date: (b)(6) 2025.Unknown if patient missed a dose.Unknown if an adverse event took place.Unknown if patient has pictures to provided.Unknown if pump is available for return.No further information, details, or dates provided.Dose and frequency: infuse 11gm (55ml) under the skin every 2 weeks.Max infusion rate up to 15-25ml per hr per injection site or as instructed by prescriber." additional information was received providing patient information and the serial number of the pump involved.The pump listed in this report has not been received by koru medical.Koru medical is currently investigating this event.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.
Additional Manufacturer Narrative
A capa was previously initiated by koru medical to investigate syringe ejection malfunctions.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: FREEDOM60®
• Common Device Name: FREEDOM60 INFUSION PUMP
• Manufacturer (Section D): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ
• Manufacturer (Section G): KORU MEDICAL SYSTEMS; 100 corporate drive; mahwah NJ 07430
• Manufacturer Contact: christine trefethen ; 100 corporate drive; mahwah, NJ 07430 ; 8456105572
• MDR Report Key: 23556455
• Report Number: 1318360-2025-00024
• Device Sequence Number: 15985650
• Product Code: FRN
• UDI-Device Identifier: 00659443004450
• UDI-Public: 00659443004450
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: F10050-A
• Device Lot Number: A.86544
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 12/19/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIZENTRA 20% PFS
• Patient Age: 14 YR
• Patient Sex: Female