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

Model Number	F10050
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Koru medical became aware of mw5164195 received through the fda medwatch program stating "patient reported that their freedom60 pump is not winding and the black plunger is stuck at top.Patient reported the pump shot syringe out.Unknown if patient has missed dose.Unknown if patient experienced an adverse event as a result.Unknown if patient has defective device on hand.All known information is contained on this form.Pharmacy is replacing pump.Pump serial number was not reported.Indications: common variable immunodeficiency, unspecified; selective deficiency of immunoglobulin g [igg] subclasses; common variable immunodeficiency with predominant abnormalities of b-cell numbers and function.Reported to (b)(6) by: patient/caregiver." no adverse events were reported to have occurred as a result of this event.A good faith effort was sent to the initial reporter on 24-jan-2025 for additional information.A response was received providing patient information and stated the reporter did not provide the serial number of the pump involved, therefore it is unknown.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 SYRINGE INFUSION SYSTEM
• 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 ; 8456105572
• MDR Report Key: 21356088
• Report Number: 1318360-2025-00005
• Device Sequence Number: 20754393
• Product Code: FRN
• UDI-Device Identifier: 00659443000001
• UDI-Public: 00659443000001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/11/2025
• 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 Age: 60 YR
• Patient Sex: Female