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	07/07/2026
Type of Reportable Event	Malfunction

• Brand Name: FREEDOM60®
• Common Device Name: Freedom60 Infusion Pump
• Manufacturer (Section D): KORU Medical Systems; 100 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): KORU Medical Systems; 100 corporate drive; mahwah NJ 07430
• Manufacturer Contact: christine trefethen ; 100 corporate drive; mahwah, NJ 07430 ; +1(845)610-5578
• MDR Report Key: 50434823
• Report Number: 1318360-2026-00020
• Device Sequence Number: 9479267
• Product Code: FRN
• UDI-Device Identifier: 00659443004450
• UDI-Public: 00659443004450
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K231918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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.87522
• 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: 08/04/2026
• Initial Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 12/16/2025
• 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
• Patient Sex: Female