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	09/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of mw5177470 received through the fda medwatch program stating "patient reports their freedom pump, serial number (b)(6), is not working correctly, states it is defective.Patient states during their hizentra infusion, yesterday, the syringe flew out of the pump and the patient had to hold the syringe down during the infusion.Patient confirmed the flow rate tubing was attached.Patient did not miss a dose, nor have an interruption in therapy and did not report an adverse event due to malfunctioning pump.The pharmacy is replacing the pump and the malfunctioning pump will be returned, box has been sent.Unknown if md is aware.No further information, details, or dates provided.Indication: myelin oligodendrocyte glycoprotein antibody disease." no further information was provided at the time of this report.Follow up with the initial reporter is being conducted for additional details.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.
Event or Problem Description
Koru medical received additional information on 04-dec-2025 providing patient information and the serial number of the pump involved.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: 23681074
• Report Number: 1318360-2025-00028
• Device Sequence Number: 13190742
• 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,Followup
• Report Date (Section B): 12/30/2025

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.87061
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 06/25/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HIZENTRA 20% PFS (1 GM TOTAL).; HIZENTRA 20% PFS (10 GM TOTAL).; HIZENTRA 20% PFS (4 GM TOTAL).
• Patient Age: 38 YR
• Patient Sex: Female