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	11/14/2025
Type of Reportable Event	Malfunction
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 became aware of a report stating "during setup, the patient stated they set everything up as usual and was just starting the priming.When the pump was turned on, the black tab sprung forward quickly from the back and ejected the syringe forcefully out, a few feet away and onto the floor.The tip of the syringe and the tubing flange were both cracked after impact.The black tab on the pump will not rewind, so the internal spring mechanism must have failed suddenly and forcefully.The patient sealed and bagged the syringe and tubing and will return with the pump and stated the hizentra and supplies will need to be replaced.The pump had been stored properly and has not been dropped or damaged." a return material authorization was initiated by koru medical for product return.The pump listed in this report has not been received by koru medical at this time.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.

• 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: 23804418
• Report Number: 1318360-2025-00031
• Device Sequence Number: 9360540
• Product Code: FRN
• UDI-Device Identifier: 00659443004450
• UDI-Public: 00659443004450
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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.86215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 06/26/2024
• 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
• Patient Sex: Unknown